Food and Drug Administration

1645:, though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play a role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. 1933: 682: 2033: 1394: 7656: 716: 942: 4459:

well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.

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more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.)

7162: 7133: 288: 1844: 9350: 7851: 2466: 2478: 9361: 8229: 1226:. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ( 1578: 1443: 1341: 1067: 980: 9381: 9391: 9371: 9340: 2454: 1951:, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The Act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the 2490: 707:. Each district comprises a main district office and a number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. 645:, and several fragmented office buildings. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the 1218:. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in 1967:

authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration. This name was shortened to the Food and Drug Administration (FDA) three years later.

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review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the

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drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether the drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs.

2277:-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. In the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate. 2161:, would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses", after they have completed Phase I testing. The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The 1193:

companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an

878:(DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating the safety and labeling of their product. 2081:

access to drugs for patients with limited treatment options. All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms. Frank Young, then commissioner of the FDA, was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication.

1238:, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the 1649:

adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc.

2065:, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the 894:. There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like 2384:

To standardize, automate and streamline the flow of regulatory data, FDA introduced an Electronic Submissions Gateway (ESG) in 2006. This gateway allows reporting organizations to send regulatory submissions to different centers over the internet, packaged in a center-specific format and enveloped as

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as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. Children react differently to the drugs because of many reasons, including size, weight, etc. There were several reasons that few medical trials were done with

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Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition.

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of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. The AIDS crisis created some political efforts to streamline the approval process. However, these limited reforms were targeted for AIDS drugs,

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and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections. Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life-threatening diseases, and expanded pre-approval

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However, on December 29, 2022, President Biden signed the '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious

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In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the

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Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA

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In an initial FDA attempt to address this issue they produced the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs that had not been tested for pediatric safety and efficacy to bear a disclaimer to that

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After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event

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The drug advertising regulation contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a

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The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or

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Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market... This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale

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in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. The FDA approved Vioxx in 1999, and initially hoped it would be safer than previous NSAIDs due to its reduced risk of intestinal tract bleeding. However, a number

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to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority. The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for

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Clearance requests are required for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected

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is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process

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drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival

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The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018, the agency published an online "black list", in which it named

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is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and

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As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the post-marketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk

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industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations were incorporated

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CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of

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and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding

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In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the

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that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use

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that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative"

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The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and

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Earlier this month, we announced that we are postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold. Today, we're announcing that for the health and

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For WebTrader, which is recommended for manual, small-volume submissions, users would typically install a client application on their computers and upload the package through it to FDA server. In AS2, which is recommended for automated or high-volume submissions, users can use any standard AS2

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The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's

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Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19

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In two instances, state governments have sought to legalize drugs that the FDA has not approved. Under the theory that federal law, passed pursuant to Constitutional authority, overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for

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The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and the issuance of enforcement letters to pharmaceutical manufacturers.

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was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of the regulated industries. Rather, OCI agents pursue and develop cases when

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and protect users from their unintended use. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. Incorporation of the guidelines during the development phase of these apps has been proposed for expedited market entry and clearance.

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The Critical Path Initiative is the FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled

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With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The

382:(FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating 1800:

issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness" and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries."

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into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove

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Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of

8970: 1638:). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect. 5450: 1167:

can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many

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Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary, techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984

732:(e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the 1905:, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by 2363:(ANDA) process. This precluded the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed. 2403:

The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens. As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $

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In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials for reforms in the FDA's procedures for pre- and post-market drug safety regulation.

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Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug

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safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on

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As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example,

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journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including

1124:. The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . 4660: 3193: 1661:(CVM) is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of 1692:

The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of

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for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.

2254:. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations. 3224: 4445: 2172:

not for the broader market. This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.

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individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of

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raised concerns that food is not a high priority at the FDA. The report explains the FDA has structural and leadership problems in the food division and is often deferential to industry. This might be attributed to

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These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market. One of the most important statutes in establishing the modern American pharmaceutical market was the 1984

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to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicine medical research, economics,

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Medical Officer Alexander Fleming, M. D., examines a portion of a 240-volume new drug application around the late 1980s. Applications grew considerably after the efficacy mandate under the 1962 Drug Amendments.

7575: 1634:, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see 871:. Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. 2412:

report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the

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uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different

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effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of

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have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged. In November 2011, Federal judge

6666: 4129: 6633:"To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. (2007; 110th Congress H.R. 1038) – GovTrack.us" 6073:

due to the public health consequences of abuse...: "We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse.

3103: 5928: 5171: 5362: 3628: 8965: 7839: 744:. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of a case. 6882: 6142: 1515:, as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&C Act, and it includes products from the simple 3791: 7645: 3547: 3517: 7568: 4917: 5012: 4240: 2069:(ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and 7111:

Medical algorithms are less transparent, far more complex, more likely to reflect preexisting human bias, and more apt to evolve (and fail) over time than medical devices in the past.

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in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it ineffective. The second wave concerned

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Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of

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of pre and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and results from the APPROVe trial in 2004 conclusively demonstrated this.

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Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived

4339: 4589: 7817: 7561: 4529: 6350: 1859:. The FDA's research efforts include the areas of biologics, medical devices, drugs, women's health, toxicology, food safety and applied nutrition, and veterinary medicine. 5193: 2385:

a GNU-compatible .tar.gz file, through either a FDA-specific WebTrader application or via a more generic B2B communication protocol called AS2 (Applicability Statement 2).

1283:, but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a 5141: 4729: 3762: 1748:

of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The

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Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "

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antitoxin derived from tetanus-contaminated serum caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named

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children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective.

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The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America.

9133: 3684: 3246: 1736:, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny. The 6203:

Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering: Bartley J. Madden: 9781934791325: Amazon.com: Books

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and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the

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to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become

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properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with, in essence, creating the modern generic drug industry.

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On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the

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Karki L (2005). "Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman Act, Regulatory Amendments and Implications for Drug Patent Enforcement".

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Yetisen AK, Martinez-Hurtado JL, da Cruz Vasconcellos F, Simsekler MC, Akram MS, Lowe CR (March 2014). "The regulation of mobile medical applications".

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Kovitwanichkanont T, Driscoll T (September 2018). "A comparative review of the isotretinoin pregnancy risk management programs across four continents".

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FDA is an agency within the Department of Health and Human Services and consists of nine Centers and Offices, which are listed on the menu to the left.

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approved a new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations.

6238: 6059: 6007: 5936: 5336: 5274:"Notice: Regulatory Cooperation Council (RCC) Over-the-Counter (OTC) Products: Common Monograph Working Group: Selection of a Monograph for Alignment" 5163: 4980: 3281: 9420: 9128: 8584: 7704: 7290: 7265: 5772: 1729: 1682: 1327:(FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. 6607: 6033: 2389:

software to transmit the package to FDA by including additional routing details on top of standard AS2, in the form of custom HTTP request headers.

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possession and sales of these substances, even in states where they are legal under state law. The first wave was the legalization by 27 states of

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to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The

1155:, FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional 5418: 3783: 2638: 17: 7847: 9440: 8265: 8179: 7230: 7167: 5556: 5333:"Press Announcements - FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids" 3513: 2266: 2137: 1815:

A more recent example of the FDA's international work is their 2018 cooperation with regulatory and law-enforcement agencies worldwide through

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for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.

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allowing doctors to recommend cannabis for glaucoma or the side effects of chemotherapy, a more widespread trend began in California with the

2048:, but caused birth defects and even the death of thousands of babies when taken during pregnancy. American mothers were largely unaffected as 9435: 9020: 8012: 7514: 5230:"PM and U.S. President Obama announce shared vision for perimeter security and economic competitiveness between Canada and the United States" 5002: 4247: 3434: 2398: 2168: 1808:

undertook a "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter

1665:

are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by the

1595: 1460: 1358: 1084: 997: 448:. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. 6497:

Politis P (2005). "Transition From the Carrot to the Stick: The Evolution of Pharmaceutical Regulations Concerning Pediatric Drug Testing".

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With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Ronald Sherman permission to produce and market

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Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s,

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Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public.

1508: 962:

or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to

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applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the

1242:

filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.

9049: 3826: 3723: 1160: 5950: 3569: 9093: 8955: 7759: 4533: 737: 6440:

Qato DM, Alexander GC (October 2011). "Improving the Food and Drug Administration's mandate to ensure postmarketing drug safety".

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The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the

9063: 7235: 1666: 1321: 1239: 954: 946: 930: 823: 811: 650: 516: 474: 460: 236: 113: 39: 6998:

Fain K, Daubresse M, Alexander GC (July 2013). "The Food and Drug Administration Amendments Act and postmarketing commitments".

6784: 5674: 5256:"United States-Canada Regulatory Cooperation Council (RCC) Joint Action Plan: Developing and implementing the Joint Action Plan" 3746: 1819:

as part of Operation Pangea XI. The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of

625:

Since 1990, the FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the

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recognized as safe, and/or is subjected to the requirement for pre-market notification without having a satisfied requirement.

859:, added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and 418: 309: 7147: 4939: 2843: 1148:

program. These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary.

826:. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. 9415: 9054: 9002: 8907: 7992: 7184: 7078: 7040: 6802: 6394: 6211: 5867: 4764: 4113: 3941: 3756: 2270: 2201: 803:

dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from

686: 6843: 4818: 4272: 9394: 9257: 9068: 8997: 8922: 8741: 7677: 7300: 5906: 4019:

Brown WV, Bramlet DA, Ross JL, Underberg JA (October 14, 2016). "JCL roundtable: Risk evaluation and mitigation strategy".

2614: 2185: 2029:

in 1951. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.

2006: 1686: 1422: 845: 670: 379: 5972:

Richert L (2009). "Reagan, Regulation, and the FDA: The US Food and Drug Administration's Response to HIV/AIDS, 1980–90".

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brought increased governmental and institutional hurdles to approval of these clinical trials, and greater concerns about

2213:, law, public policy, public health, and the allied health professions, as well as current and former executives from the 929:(MCMi), with programs funded by the federal government. It helps support "partner" agencies and organisations prepare for 9245: 9123: 8019: 8007: 7773: 7763: 7664: 5614: 5277: 3858: 2608: 1852: 1755:

In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.

1737: 1207: 614: 1913:, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the 9425: 8258: 7360: 6086: 5519: 5229: 4418: 4210: 2764: 2542: 2527: 2157: 1749: 1324: 1280: 898:(Teflon) are not and cannot be considered as FDA Approved, but rather, they are a "FDA Compliant" or "FDA Acceptable". 819: 729: 704: 6723: 4502: 3457: 9262: 9221: 9186: 9171: 9153: 9078: 8857: 7801: 7305: 7260: 7059: 6988: 6951: 6164: 4686:

Modric S (September 2013). "Regulatory framework for the availability and use of animal drugs in the United States".

4155: 3404: 2590:

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

2537: 1617: 1482: 1380: 1106: 1019: 724: 261: 4442:"Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections" 2114:

from the market, it was the first request in FDA history to recall an effective drug over its potential for misuse.

9267: 9103: 9034: 9029: 8117: 8002: 7997: 7961: 6956: 5255: 4439: 2602: 2565: 2522: 2360: 2293:, which awards a transferable "priority review voucher" to any company that obtains approval for a treatment for a 2066: 1889:. The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the 1714: 1662: 1194: 915: 5463: 4613:"A perspective on the safety of cosmetic products: a position paper of the American Council on Science and Health" 3311: 3042: 9206: 9113: 8977: 8892: 8655: 4876: 4472: 4363:"Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic" 2262:. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority. 2098: 1741: 1284: 815: 733: 634: 4303: 4182: 2927: 9235: 9108: 8945: 8912: 7982: 7767: 7542: 7310: 7250: 5827: 5579: 3125: 2956: 2015: 1890: 1871:

project was created to enable easy access of the data for the public and was officially launched in June 2014.

1698: 1658: 1599: 1464: 1362: 1088: 1001: 662: 534: 484: 456: 406: 251: 194: 6769: 5034: 799:

food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable.

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Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering

2274: 2165:

declined to hear the case, and the final decision denied the existence of a right to unapproved medications.

2057:

pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form.

1991: 1685:. This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the 1426: 1407: 1310: 5999: 2786: 2735: 1163:(REMS) for some drugs that require actions to be taken to ensure that the drug is used safely. For example, 9374: 7393: 6229: 6055: 5332: 4971: 3277: 699: 638: 543: 441: 266: 5776: 9294: 8992: 8950: 8304: 8036: 7977: 7806: 7597: 7245: 6599: 6029: 2294: 1932: 1898: 1306: 610: 528: 246: 7553: 7138: 6567: 681: 9289: 7448: 5735:"Making Food Standard: The U.S. Food and Drug Administration's Food Standards of Identity, 1930s–1960s" 2444: 2340: 1953: 1152: 1037: 5410: 4440:

Stephen M. Hahn M.D., Commissioner of Food and Drugs - Food and Drug Administration (March 18, 2020).

9319: 9039: 7519: 7388: 5552: 4104:

Cohen L (1990). "Government Policies and Programs – United States – Generic Drug Scandal".

3972:"Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies" 2682: 2632: 2571: 2110: 2053: 2032: 2026: 2002: 1998:

tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.

1524: 1418: 364: 7176: 6828: 1413:

The original authority for government regulation of biological products was established by the 1902

9181: 8542: 8534: 8377: 8068: 5697: 2710:

The quoted text from the source indicates "9" but the actual count from the website indicates "14".

2596: 2328: 1393: 1121: 891: 6568:"Section 529 Rare Pediatric Disease Priority Review Voucher Incentive Program, Public Law 112-144" 6113:"Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products" 5194:"Joint Statement by President Obama and Prime Minister Harper of Canada on Regulatory Cooperation" 3629:"Alliance for Biosecurity applauds subcommittee efforts to sustain medical countermeasure funding" 3426: 1555:

defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.

715: 637:(GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the 9161: 9073: 8514: 8389: 7987: 7887: 7778: 7378: 5384: 4882: 4792: 4555: 3184:"The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem?" 3156: 2905: 2626: 2286: 1902: 1588: 1453: 1351: 1276: 1211: 1135:

refers to the practice of prescribing a drug for a different purpose than what the FDA approved.

1077: 990: 895: 855:

The FDA subdivides substances that it regulates as food into various categories—including foods,

762: 630: 433: 123: 4361:

Rizk JG, Forthal DN, Kalantar-Zadeh K, Mehra MR, Lavie CJ, Rizk Y, et al. (February 2021).

3902: 3875: 1725:

way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf.

394:. In addition, the FDA takes control of diseases in the contexts varying from household pets to 9229: 9149: 9044: 8867: 8746: 8160: 8076: 7912: 7315: 6400: 6309: 6262:"Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial" 6260:

Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, et al. (March 2005).

2812: 2128:

Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.

1948: 849: 841: 5859: 5853: 5309: 3377: 1523:. CDRH also oversees the safety performance of non-medical devices that emit certain types of 9251: 9201: 9196: 8940: 8688: 7917: 7726: 7473: 4848: 4752: 2512: 2409: 2205: 2189: 2049: 1918: 1414: 399: 341: 5060: 4757:

Vaccines and diagnostics for transboundary animal diseases: Ames, Iowa, 17-19 September 2012

9364: 8678: 8507: 8362: 7428: 5464:

National Research Council (US) Division of Health Promotion and Disease Prevention (1985).

2470: 2348: 2259: 2105: 2094: 1995: 1994:

for five years, but was rapidly enacted into law following the public outcry over the 1937

1033: 941: 885: 414: 32: 5929:"FDA Website: Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS" 8: 9324: 9083: 8781: 7872: 7867: 7443: 7032: 5958: 5258:(Press release). Office of the Prime Minister of Canada. December 7, 2011. Archived from 4753:"Translating research into licensed vaccines and validated and licensed diagnostic tests" 3814: 3711: 3577: 2584: 2560: 2372: 1886: 1044:

first. A drug that is approved is said to be "safe and effective when used as directed".

925: 860: 642: 626: 429: 372: 344: 55: 9380: 6782: 6414: 2307:

paper: "Developing Drugs for Developing Countries". President Obama signed into law the

8982: 8935: 8877: 8761: 8433: 7892: 7877: 7423: 7418: 7161: 7132: 6946: 6816: 6755: 6291: 6201: 5819: 4642: 4387: 4362: 4079: 3996: 3971: 2902:"FDA's International Posts: Improving the Safety of Imported Food and Medical Products" 1959: 1944: 1773: 1227: 1159:, called Phase IV trials. In some cases, the FDA requires risk management plans called 410: 333: 287: 7106: 6737: 5666: 1495: 768:

According to Forbes, pharmaceutical firms provide 75% of the FDA's drug review budget

592: 451: 199: 9309: 9118: 8804: 8438: 8423: 8405: 8319: 8138: 8060: 7922: 7408: 7171: 7074: 7055: 7036: 7015: 6984: 6961: 6926: 6808: 6798: 6705: 6549: 6457: 6390: 6283: 6207: 5863: 5811: 5754: 5115: 5110: 5093: 4760: 4703: 4634: 4392: 4109: 4071: 4036: 4001: 3880: 3752: 3373: 2149: 2145: 2090: 2022: 2011: 356: 352: 337: 6687: 6632: 5823: 4646: 1777:(medicinal leeches) as the second living organism legal to use as a medical device. 8960: 8872: 8852: 8700: 8670: 8286: 7530:

Regulation of food and dietary supplements by the U.S. Food and Drug Administration

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Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation

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Regulation of food and dietary supplements by the U.S. Food and Drug Administration

6922: 5580:"The surprising journey from a horse named Jim to stem cell therapies at UC Davis" 3945: 9176: 8882: 8844: 8814: 8660: 8593: 8458: 8443: 8367: 8334: 7468: 7383: 5445: 4378: 4280: 2494: 2335:. Many of these drugs are extremely expensive; for example, the anti-cancer drug 2298: 2251: 2246:

Also, the belief that children are ethically restricted in their ability to give

1936: 1914: 1843: 1764: 1745: 1528: 1520: 1156: 387: 9384: 6875:"Where the dollars go: Lobbying a big business for large food and beverage CPGs" 5902: 5465: 1197:(ANDA). 80% of prescription drugs sold in the United States are generic brands. 863:. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, 9299: 8463: 8428: 8324: 8102: 8044: 7605: 7488: 7463: 7458: 7433: 7398: 7090: 6909:

Givel M (December 2005). "Philip Morris' FDA gambit: good for public health?".

5610: 5198: 4699: 4032: 2303: 1910: 1828: 1797: 1540: 1512: 1032:

New drugs receive extensive scrutiny before FDA approval in a process called a

395: 360: 6171: 5750: 5276:. Canada's Action Plan. Government of Canada. January 10, 2013. Archived from 4629: 4612: 3987: 3483: 1511:(CDRH) is the branch of the FDA responsible for the premarket approval of all 9409: 9304: 8824: 8632: 8493: 8473: 8384: 8349: 8052: 7850: 7498: 7483: 7438: 7211: 7153: 6534: 6517: 5773:"Report of Congressman Morris Udall on thalidomide and the Kefauver hearings" 5758: 5508:"How Chemists Pushed for Consumer Protection: The Food and Drugs Act of 1906" 4308: 3004: 2990: 2620: 2507: 2432: 2210: 1809: 1805: 1710: 1635: 1544: 1223: 1172:

drugs have REMS programs to avoid addiction and diversion of drugs. The drug

856: 422: 317: 190: 145: 132: 6786:

The Future of Drug Safety: Promoting and Protecting the Health of the Public

6379:

The Future of Drug Safety: Promoting and Protecting the Health of the Public

5507: 5441:"FDA opens new drug database to public; hiring site draws investor interest" 5233: 5164:"The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk" 4410: 3455: 3332: 2760: 9354: 9314: 8829: 8650: 8642: 8612: 8483: 8468: 8314: 7493: 7157: 7019: 7011: 6930: 6709: 6553: 6461: 6453: 6287: 5815: 5304: 5232:(Press release). Prime Minister of Canada. February 4, 2011. Archived from 5119: 4707: 4638: 4396: 4075: 4040: 4005: 3884: 3605:. U.S. Food and Drug Administ ration: Emergency Preparedness and Response. 2344: 2320: 2239: 2214: 1987: 1824: 1793: 1733: 1219: 1173: 911: 804: 437: 6973: 6965: 3942:"MedWatch: The FDA Safety Information and Adverse Event Reporting Program" 3392: 1230:

and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes.

9344: 8930: 8887: 8819: 8799: 8776: 8751: 8555: 8550: 8528: 8521: 8478: 8448: 8418: 8274: 7614: 7583: 6969: 6844:"How the FDA's food division fails to regulate health and safety hazards" 6278: 6261: 5985: 5359:"Transaction laundering in 2019 – time to review the monitoring strategy" 2517: 2458: 2414: 2041: 1976: 1926: 1781: 1330: 1164: 1120:

Advertising and promotion for over-the-counter drugs is regulated by the

907: 445: 368: 321: 6139:"The US Government Has Sent This Guy 300 Joints Each Month for 34 Years" 5259: 4122: 2319:

Since the 1990s, many successful new drugs for the treatment of cancer,

2222:

into drafts of the PDUFA IV amendment, which was signed into law as the

2052:

of the FDA refused to authorize the medication for market. In 1962, the

9145: 8897: 8862: 8791: 8578: 8453: 8413: 8282: 8243: 8084: 6701: 6475:

Temeck J (November 2010). "Pediatric Product Development in the U.S.".

5849: 5300:"N2018-123 / 2018 / News / News and media / Internet / Home - INTERPOL" 3303: 3034: 2482: 1922: 1856: 1602: in this section. Unsourced material may be challenged and removed. 1536: 1516: 1467: in this section. Unsourced material may be challenged and removed. 1365: in this section. Unsourced material may be challenged and removed. 1314: 1215: 1189: 1091: in this section. Unsourced material may be challenged and removed. 1004: in this section. Unsourced material may be challenged and removed. 864: 7052:

Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet

6544: 4067: 1867:

The FDA has collected a large amount of data through the decades. The

1558: 689:

is the headquarters of the National Center for Toxicological Research.

9191: 8902: 8834: 8809: 8771: 8736: 8728: 8710: 8695: 8683: 8627: 8604: 8572: 8567: 8357: 7206: 5807: 4556:"What does it mean when FDA "clears" or "approves" a medical device?" 2301:

faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006

1979: 1971: 1906: 1702: 1260: 1256: 1132: 959: 921: 7646:

Office of the National Coordinator for Health Information Technology

5791: 2477: 1577: 1442: 1340: 1066: 1040:, the agency has worked to make the drug-approval process go faster. 979: 810:

The FDA frequently works with other federal agencies, including the

9166: 8756: 8705: 8561: 8501: 8329: 8299: 7897: 6794: 6386: 5003:"FDA Announces Plan To Cut Level Of Nicotine Allowed In Cigarettes" 2428: 2422: 2086: 1983: 1816: 1145: 792: 741: 329: 3931:

21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences

3333:

Center for Food Safety and Applied Nutrition (September 9, 2020).

92:

Food, Drug, and Insecticide Administration (July 1927 – July 1930)

8622: 8339: 8309: 6783:

Committee on the Assessment of the US Drug Safety System (2006).

2336: 2324: 1868: 1251: 1235: 1177: 391: 348: 325: 4473:"3 USDA meat inspectors dead, about 145 diagnosed with COVID-19" 1982:, mascara that could cause blindness, and worthless "cures" for 564:

Office of Policy, Legislation, and International Affairs (OPLIA)

8766: 8724: 8294: 4503:"About the Center for Biologics Evaluation and Research (CBER)" 4304:"The FDA recently halted trials on a potential Ebola treatment" 3456:

Center for Food Safety and Applied Nutrition (March 17, 2020).

3188: 2077: 1820: 1169: 868: 383: 4688:

The Veterinary Clinics of North America. Small Animal Practice

4360: 2555:

Food and Drug Administration Safety and Innovation Act of 2012

2309:

Food and Drug Administration Safety and Innovation Act of 2012

2131: 1695:

R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration

425:

is the current Commissioner as of 17 February 2022.

8720: 8372: 7907: 7882: 7093:(January 2022). "Medical Algorithms Need Better Regulation". 6415:"Food and Drug Administration Amendments Act (FDAAA) of 2007" 6259: 6058:(Press release). Food and Drug Administration. June 8, 2017. 6056:"FDA requests removal of Opana ER for risks related to abuse" 2273:

reauthorized these provisions and allowed the FDA to request

2181: 1835:

schemes in order to uncover the complex online drug network.

1548: 1275:

treatment being developed by Canadian pharmaceutical company

1272: 1049: 9339: 4759:. Karger Medical and Scientific Publishers. pp. 53–54. 3093: 2453: 1831:

prescription drugs to U.S. consumers. The agency focused on

7902: 7637:

Office of the Deputy Secretary of Health and Human Services

5215: 5053: 4793:"Does FDA have the authority to regulate tobacco products?" 4751:

Hill R Jr, Foley P, Clough N, Ludemann L, Murtle D (2013).

4661:"Modernization of Cosmetics Regulation Act of 2022 (MoCRA)" 3712:"Regulatory Monitors: Policing Firms in the Compliance Era" 2670:

Federal Commission for the Protection against Sanitary Risk

96: 8123:

List of pharmaceutical manufacturers in the United Kingdom

7168:

Online books by United States Food and Drug Administration

6084: 4910:"Big Tobacco Gets Top First Amendment Lawyer for New Suit" 4158:. U.S. Food & Drug Administration. December 20, 2019. 3214: 1397:

FDA scientist prepares blood donation samples for testing.

1188:

Generic drugs are chemical and therapeutic equivalents of

852:

of both the composition and the health benefits of foods.

8617: 7737:

Substance Abuse and Mental Health Services Administration

7073:. Boca Raton, FL: CRC Press, Taylor & Francis Group. 5007: 4053: 4018: 1432: 5027: 4663:. U.S. Food and Drug Administration. December 14, 2023. 4433: 3815:"The New Gatekeepers: Private Firms as Public Enforcers" 3546:. U.S. Food and Drug Administration. December 20, 2019. 2985:

Coordinates of FDA Headquarters at White Oak, Maryland:

2815:. U.S. Food and Drug Administration. February 17, 2022. 2175: 649:(OC), the Office of Regulatory Affairs (ORA), the 4750: 3790:. U.S. Food and Drug Administration. October 19, 2023. 3335:"Full Text of the Food Safety Modernization Act (FSMA)" 2379: 38:

For the department concerned with food production, see

8113:

List of off-label promotion pharmaceutical settlements

6997: 5608: 5330: 4728:. U.S. Food and Drug Administ ration. April 11, 2019. 3490:. U.S Food and Drug Administration. February 4, 2020. 3159:. US Food and Drug Administration. November 26, 2021. 2533:

Food and Drug Administration Modernization Act of 1997

2267:

Food and Drug Administration Modernization Act of 1997

2063:

Drug Price Competition and Patent Term Restoration Act

1331:

Vaccines, blood and tissue products, and biotechnology

1287:

that began in late March 2014 and ended in June 2016.

890:

The FDA does not approve applied coatings used in the

463:. The agency consists of fourteen Centers and Offices. 316:. The FDA is responsible for protecting and promoting 7710:

National Institute for Occupational Safety and Health

7585:

United States Department of Health and Human Services

3661:. U.S. Food and Drug Administ ration. June 21, 2022. 2442: 1990:. The resulting proposed law did not get through the 1429:; this authority was transferred to the FDA in 1972. 1210:

resulted from a complaint brought against the FDA by

609:

FDA headquarters facilities are currently located in

7634:

Office of the Secretary of Health and Human Services

6772:. U.S. Food and Drug Administ ration. June 10, 2024. 5885:

Journal of the Patent & Trademark Office Society

4106:

The New Book of Knowledge – Medicine And Health

1417:, with additional authority established by the 1944 966:: drugs that are not based on existing medications. 920:

Medical countermeasures (MCMs) are products such as

886:"FDA-Approved" vs. "FDA-Accepted in Food Processing" 710: 620: 9099:

2024 United Kingdom Shigatoxigenic E. coli outbreak

7742:

Center for Behavioral Health Statistics and Quality

7126: 6726:. U.S. Food and Drug Administ ration. May 12, 2023. 6115:. U.S. Food and Drug Administration. Archived from 4972:"Judge Temporarily Blocks Graphic Cigarette Labels" 4532:. U.S. Food and Drug Administration. Archived from 4338:. U.S. Food and Drug Administration. May 21, 2020. 4273:"FDA CDER Handbook: Over-the-Counter Drug Products" 4246:. U.S. Food and Drug Administration. Archived from 4198:

Almost 80% of prescription drugs sold are generics.

3944:. U.S. Food and Drug Administration. Archived from 3570:"FDA Approved Coatings vs. FDA Acceptable Coatings" 3217:"Emergency Use Authorization--Archived Information" 3128:. U.S. Food and Drug Administration. May 21, 2020. 2689:

Medicines and Healthcare products Regulatory Agency

2549:

Food and Drug Administration Amendments Act of 2007

2291:

Food and Drug Administration Amendments Act of 2007

2265:While this debate was unfolding, Congress used the 2224:

Food and Drug Administration Amendments Act of 2007

2188:(NSAID) now estimated to have contributed to fatal 2014:. The law also authorized the FDA to issue minimum 876:

Dietary Supplement Health and Education Act of 1994

558:

Office of Minority Health and Health Equity (OMHHE)

280: 6515: 6344: 6342: 6228: 6000:"Medicinal Marijuana: A Patient-Driven Phenomenon" 4970: 4875: 4819:"Cigarette Makers, FDA Clash Over New Graphic Ads" 3784:"The Office of Prescription Drug Promotion (OPDP)" 2846:. Food and Drug Administration. February 9, 2011. 2339:costs $ 55,000 for a year of treatment, while the 2044:was marketed for the relief of general nausea and 2018:for all mass-produced foods to reduce food fraud. 1138: 7705:National Center for Injury Prevention and Control 7337:Title 21 of the Code of Federal Regulations (CFR) 7291:Family Smoking Prevention and Tobacco Control Act 7266:Office of Global Regulatory Operations and Policy 2930:. Food and Drug Administration. August 29, 2014. 1847:FDA lab at Building 64 in Silver Spring, Maryland 1758: 1683:Family Smoking Prevention and Tobacco Control Act 1290: 1208:United States House Energy and Commerce Committee 901: 719:Jamaica, Queens, New York Regional Office - USFDA 9407: 7700:Agency for Toxic Substances and Disease Registry 6226: 4940:"Tobacco Cos. Get Allies in Warning Label Fight" 4411:"Comirnaty and Pfizer-BioNTech COVID-19 Vaccine" 3969: 3659:"Center for Drug Evaluation and Research | CDER" 3094:Office of Regulatory Affairs (October 7, 2021). 2280: 1838: 6627: 6625: 6339: 6085:Office of the Commissioner (February 8, 2019). 6022: 5775:. University of Arizona Library. Archived from 5387:. Food and Drug Administration. June 18, 2009. 4505:. Food and Drug Administration. March 2, 2017. 3458:"Dietary Supplement Products & Ingredients" 3280:(Press release). Food and Drug Administration. 2639:Federal Institute for Drugs and Medical Devices 2347:costs $ 200,000 per year, and must be taken by 2311:, which extended the authorization until 2017. 1853:carries out research and development activities 829: 693: 7068: 5667:"Milestones in U.S. Food and Drug Law History" 3215:Office of the Commissioner (August 31, 2021). 2904:. Food and Drug Administration. Archived from 2734:. Food and Drug Administration. Archived from 2366: 2314: 2138:Compassionate Investigational New Drug program 2025:" drugs was securely codified into law by the 1641:According to the industry advocacy group, the 378:The FDA's primary focus is enforcement of the 102:Division of Chemistry, USDA (established 1862) 8259: 7833: 7619:Deputy Secretary of Health and Human Services 7569: 7515:Criticism of the Food and Drug Administration 7192: 6841: 6439: 5842: 4241:"Regulation of Nonprescription Drug Products" 3540:"Dietary Supplement Ingredient Advisory List" 3514:"Dietary Supplement Ingredient Advisory List" 2574:1962 – required "proof-of-efficacy" for drugs 2399:Criticism of the Food and Drug Administration 2271:Best Pharmaceuticals for Children Act of 2007 1527:. Examples of CDRH-regulated devices include 549:Office of Clinical Policy and Programs (OCPP) 9274:Spanish Agency for Food Safety and Nutrition 9089:2017–2018 South African listeriosis outbreak 8988:1985 Austrian diethylene glycol wine scandal 7855:Pharmaceutical industry in the United States 7786:Centers for Medicare & Medicaid Services 7722:Health Resources and Services Administration 7673:Office of the Assistant Secretary for Health 7241:Center for Food Safety and Applied Nutrition 7226:Center for Biologics Evaluation and Research 7088: 6622: 5951:"FDA report on accelerated approval process" 5876: 5792:"Policy developments in regulatory approval" 4582:"Summary of Cosmetics Labeling Requirements" 4183:"Generic Drugs: Answers to Common Questions" 3544:Center for Food Safety and Applied Nutrition 3488:Center for Food Safety and Applied Nutrition 2645:Food Safety and Standards Authority of India 2333:Center for Biologics Evaluation and Research 1787: 1632:Center for Food Safety and Applied Nutrition 1403:Center for Biologics Evaluation and Research 1285:major outbreak of the disease in West Africa 1056: 844:and interpreted by the FDA. Pursuant to the 776: 659:Center for Biologics Evaluation and Research 523:Center for Food Safety and Applied Nutrition 505:Center for Biologics Evaluation and Research 242:Center for Food Safety and Applied Nutrition 227:Center for Biologics Evaluation and Research 9212:United Kingdom food information regulations 7525:History of the Food and Drug Administration 7361:Title 21 of the United States Code (U.S.C.) 6518:"Developing drugs for developing countries" 6310:"David Graham's 2004 testimony to Congress" 5858:. New York, New York: Basic Books. p. 4679: 3876:10.1001/virtualmentor.2013.15.11.hlaw1-1311 3151: 3149: 3147: 2979: 2838: 2836: 2834: 2693:United States: Food and Drug Administration 2651:Central Drugs Standard Control Organization 2371:In 2013, a guidance was issued to regulate 2132:Patients' rights to access unapproved drugs 2122: 1881:History of the Food and Drug Administration 496:Office of the Counselor to the Commissioner 467: 8266: 8252: 8108:List of largest pharmaceutical settlements 7840: 7826: 7695:Centers for Disease Control and Prevention 7690:Agency for Healthcare Research and Quality 7576: 7562: 7256:National Center for Toxicological Research 7231:Center for Devices and Radiological Health 7199: 7185: 7160: 7131: 7071:Food policy: looking forward from the past 6724:"Setting up a WebTrader Account Checklist" 6560: 6492: 6490: 6488: 6486: 6375:"Executive Summary of the 2006 IOM Report" 6165:"Abigail Alliance Citizen Petition to FDA" 5659: 5547: 5545: 5543: 5541: 5539: 5537: 5501: 5499: 5497: 5495: 5493: 5491: 5489: 5266: 5085: 4877:"FDA Defends New Graphic Cigarette Labels" 4130:"Therapeutic Equivalence of Generic Drugs" 3847:21 CFR 202: Prescription Drug Advertising. 2664:Pharmaceuticals and Medical Devices Agency 1509:Center for Devices and Radiological Health 1501:Center for Devices and Radiological Health 655:Center for Devices and Radiological Health 598:Center for Devices and Radiological Health 571:National Center for Toxicological Research 511:Center for Devices and Radiological Health 436:. The agency has 223 field offices and 13 286: 257:National Center for Toxicological Research 232:Center for Devices and Radiological Health 31:"FDA" redirects here. For other uses, see 9050:2008 United States salmonellosis outbreak 6937: 6543: 6533: 6509: 6496: 6348: 6277: 6227:Boldrin M, Swamidass SJ (July 25, 2011). 5698:"Medical Disasters and the Growth of FDA" 5134:"FDA approves leeches as medical devices" 5109: 4628: 4464: 4386: 4156:"Abbreviated New Drug Application (ANDA)" 3995: 3970:Nelson LS, Loh M, Perrone J (June 2014). 3965: 3963: 3874: 3859:"Direct-to-consumer advertising of drugs" 3856: 3597: 3595: 3304:"Federal Register :: Request Access" 3181: 2538:FDA Food Safety Modernization Act of 2011 2233: 1939:, chief advocate of the Food and Drug Act 1618:Learn how and when to remove this message 1483:Learn how and when to remove this message 1381:Learn how and when to remove this message 1245: 1161:Risk Evaluation and Mitigation Strategies 1107:Learn how and when to remove this message 1020:Learn how and when to remove this message 555:Office of Food Policy and Response (OFPR) 493:Office of the Executive Secretariat (OES) 428:The FDA's headquarters is located in the 9421:1906 establishments in the United States 9094:2018 Australian strawberry contamination 8956:Morinaga Milk arsenic poisoning incident 8273: 7760:Administration for Children and Families 7683:Public Health Service Commissioned Corps 7049: 6516:Ridley DB, Grabowski HG, Moe JL (2006). 5732: 5637:"History of FDA's Internal Organization" 4755:. In Roth J, Richt J, Morozov I (eds.). 4530:"CDRH Mission, Vision and Shared Values" 4211:"F.D.A. Details Problems at Drug Makers" 3903:"Off-Label Drug Use in Cancer Treatment" 3744: 3275: 3144: 2831: 2755: 2753: 2417:, funding, and independence of the FDA. 2031: 1931: 1842: 1721:claiming that the graphic labels are an 1494: 1392: 940: 714: 680: 591: 450: 9431:Government agencies established in 1906 9064:2011 United States listeriosis outbreak 7236:Center for Drug Evaluation and Research 6770:"ESG Appendix F: AS2 Header Attributes" 6483: 6322:from the original on September 25, 2012 6302: 5971: 5647:from the original on September 24, 2020 5577: 5534: 5522:from the original on September 17, 2021 5486: 5091: 5035:"510(k) Premarket Notification K033391" 4328: 4162:from the original on September 23, 2020 4099: 4097: 4095: 4093: 3812: 3788:Center for Drug Evaluation and Research 3709: 3520:from the original on September 25, 2020 3516:. U.S. Food & Drug Administration. 3345:from the original on September 12, 2018 3016:FDA Headquarters at White Oak, Maryland 2117: 1681:with authority established by the 2009 1667:United States Department of Agriculture 1519:to complex devices such as implantable 1240:U.S. Securities and Exchange Commission 1200: 1151:While this remains the primary tool of 955:Center for Drug Evaluation and Research 947:Center for Drug Evaluation and Research 651:Center for Drug Evaluation and Research 517:Center for Drug Evaluation and Research 475:Department of Health and Human Services 461:Department of Health and Human Services 320:through the control and supervision of 314:Department of Health and Human Services 237:Center for Drug Evaluation and Research 214:Department of Health and Human Services 114:Federal government of the United States 40:United States Department of Agriculture 14: 9408: 9079:2015 Mozambique funeral beer poisoning 8656:Ethylenediaminetetraacetic acid (EDTA) 7610:Secretary of Health and Human Services 7054:. New York, NY: Simon & Schuster. 7026: 6669:from the original on September 4, 2015 6474: 6199: 5830:from the original on November 27, 2018 5789: 5695: 4968: 4873: 4855:from the original on September 9, 2012 4799:from the original on November 14, 2017 4732:from the original on December 12, 2019 4685: 4592:from the original on December 13, 2019 4470: 4180: 4132:. Food and Drug Administration. 1998. 3960: 3891:from the original on January 31, 2024. 3765:from the original on December 11, 2019 3592: 3364:Yadin S (2019). "Regulatory Shaming". 3163:from the original on February 24, 2022 2657:Ministry of Health, Labour and Welfare 1652: 1643:American Council on Science and Health 1433:Medical and radiation-emitting devices 1313:(PPE), in vitro diagnostic equipment, 1250:Over-the-counter (OTC) are drugs like 771: 499:Office of Digital Transformation (ODT) 419:Secretary of Health and Human Services 409:, appointed by the President with the 9441:National agencies for drug regulation 8247: 7821: 7557: 7180: 7154:Works by Food and Drug Administration 6978: 6908: 6758:. U.S. Food and Drug Administ ration. 6643:from the original on January 12, 2015 6145:from the original on October 14, 2017 6062:from the original on November 4, 2017 5909:from the original on February 2, 1998 5882: 5714:from the original on October 10, 2011 5590:from the original on January 14, 2023 5505: 5421:from the original on October 21, 2020 5391:from the original on January 14, 2012 5385:"About Science & Research at FDA" 5339:from the original on February 7, 2019 5206:from the original on January 22, 2017 5144:from the original on January 14, 2023 4950:from the original on January 12, 2015 4849:"Overview: Cigarette Health Warnings" 4667:from the original on January 22, 2024 4444:. U.S. Food and Drug Administration. 4301: 4103: 3913:from the original on January 14, 2023 3829:from the original on October 28, 2020 3794:from the original on October 23, 2023 3691:from the original on November 1, 2013 3665:from the original on January 14, 2023 3639:from the original on January 28, 2021 3460:. U.S. Food and Drug Administration. 3437:from the original on January 14, 2023 3390: 3366:Environmental Law (Lewis & Clark) 3363: 3257:from the original on January 14, 2023 3106:from the original on January 14, 2023 2882:from the original on November 1, 2013 2750: 2176:Post-marketing drug safety monitoring 9436:Regulators of biotechnology products 9370: 9258:Institute for Food Safety and Health 8998:Australian meat substitution scandal 8966:Moroccan oil poisoning disaster 1959 8742:Arsenic contamination of groundwater 7301:Federal Food, Drug, and Cosmetic Act 6610:from the original on January 6, 2022 6351:"Panel: FDA needs more power, funds" 5848: 5248: 4829:from the original on October 8, 2011 4610: 4421:from the original on August 14, 2021 4336:"Emergency Use Authorizations - FDA" 4090: 4056:International Journal of Dermatology 3196:from the original on January 3, 2023 3045:from the original on October 9, 2020 3039:National Capital Planning Commission 2862: 2615:Marketed Health Products Directorate 2380:Electronic Submissions Gateway (ESG) 2186:non-steroidal anti-inflammatory drug 2007:Federal Food, Drug, and Cosmetic Act 1752:ultimately could decide the matter. 1600:adding citations to reliable sources 1571: 1465:adding citations to reliable sources 1436: 1423:Federal Food, Drug, and Cosmetic Act 1363:adding citations to reliable sources 1334: 1089:adding citations to reliable sources 1060: 1002:adding citations to reliable sources 973: 846:Federal Food, Drug, and Cosmetic Act 755: 671:National Capital Planning Commission 567:Office of the Chief Scientist (OCS) 380:Federal Food, Drug, and Cosmetic Act 367:emitting devices (ERED), cosmetics, 9390: 9246:Food Information and Control Agency 8020:Pharmaceutical sales representative 7774:Administration for Community Living 7764:Administration for Native Americans 6885:from the original on March 19, 2022 6872: 6266:The New England Journal of Medicine 6093:from the original on April 22, 2019 6010:from the original on March 17, 2015 5559:from the original on March 16, 2015 5467:Vaccines: Past, Present, and Future 5453:from the original on June 23, 2014. 5202:(Press release). February 4, 2011. 5094:"Age-old therapy gets new approval" 5015:from the original on March 20, 2018 4920:from the original on April 11, 2015 4773:from the original on August 1, 2020 4617:International Journal of Toxicology 4316:from the original on August 6, 2014 4221:from the original on March 13, 2017 4136:from the original on April 29, 2012 3609:from the original on April 22, 2019 3603:"What are Medical Countermeasures?" 3550:from the original on April 16, 2020 3397:Yale Journal on Regulation Bulletin 3132:from the original on April 21, 2020 3075:from the original on April 23, 2019 3065:"White Oak Campus Project Schedule" 2967:from the original on April 21, 2020 2928:"About the FDA Organization Charts" 2850:from the original on April 21, 2016 2819:from the original on March 21, 2022 2793:from the original on March 22, 2015 2609:National Health Surveillance Agency 2297:. The system was first proposed by 1804:Under the RCC mandate, the FDA and 1780:The FDA also requires that milk be 1738:Association of National Advertisers 1672: 1533:airport baggage screening equipment 765:pay fees to expedite drug reviews. 540:Oncology Center of Excellence (OCE) 24: 8144:Pharmaceutical industry by country 8053:The Truth About the Drug Companies 6901: 6854:from the original on April 9, 2022 6580:from the original on March 6, 2016 6349:Henderson D (September 23, 2006). 6230:"A New Bargain for Drug Approvals" 6036:from the original on July 19, 2018 5474:from the original on June 27, 2023 5365:from the original on July 14, 2020 5174:from the original on April 4, 2021 4722:"Bovine Spongiform Encephalopathy" 4562:from the original on March 7, 2015 3494:from the original on April 3, 2020 3284:from the original on July 24, 2018 3227:from the original on June 15, 2020 2934:from the original on July 22, 2015 2543:FDA Fast Track Development Program 2528:Drug Efficacy Study Implementation 2158:Abigail Alliance v. von Eschenbach 1862: 1410:(BLA), similar to that for drugs. 1325:Food Safety and Inspection Service 1266: 969: 824:Consumer Product Safety Commission 747: 730:Title 18 of the United States Code 676: 440:located across the 50 states, the 417:. The Commissioner reports to the 25: 9452: 9263:International Food Safety Network 9187:International Food Safety Network 8908:Variant Creutzfeldt–Jakob disease 8858:Acid-hydrolyzed vegetable protein 8585:Shigatoxigenic and verotoxigenic 7802:Child Welfare Information Gateway 7261:Office of Criminal Investigations 7118: 7107:10.1038/scientificamerican0122-10 6952:Concise Encyclopedia of Economics 6421:from the original on May 25, 2009 6241:from the original on July 9, 2017 5677:from the original on May 21, 2009 5641:U.S. Food and Drug Administration 5617:from the original on May 12, 2009 5470:. National Academies Press (US). 5415:U.S. Food and Drug Administration 5098:Advances in Skin & Wound Care 5073:from the original on July 1, 2015 5041:from the original on July 9, 2021 4983:from the original on July 9, 2017 4890:from the original on July 9, 2017 4586:U.S. Food and Drug Administration 4483:from the original on May 19, 2020 4448:from the original on May 12, 2020 4342:from the original on May 17, 2020 3726:from the original on June 4, 2020 3635:. Washington, D.C. June 8, 2016. 3464:from the original on May 28, 2020 3407:from the original on May 18, 2019 3314:from the original on June 5, 2023 2961:U.S. Food and Drug Administration 2767:from the original on June 2, 2023 2359:did not include biologics in the 2323:, and other conditions have been 725:Office of Criminal Investigations 711:Office of Criminal Investigations 621:White Oak Federal Research Center 490:Office of the Chief Counsel (OCC) 262:Office of Criminal Investigations 9389: 9379: 9369: 9360: 9359: 9348: 9338: 9268:Ministry of Food and Drug Safety 9104:Kobayashi red yeast rice scandal 9035:2008 Canada listeriosis outbreak 9030:ICA meat repackaging controversy 8228: 8227: 8118:List of pharmaceutical companies 7962:American Pharmacists Association 7849: 7654: 7274: 6957:Library of Economics and Liberty 6866: 6835: 6776: 6762: 6748: 6730: 6716: 6681: 6665:. Food and Drug Administration. 6655: 6592: 6468: 6433: 6417:. Food and Drug Administration. 6407: 6367: 6253: 6220: 6193: 6157: 6131: 6105: 6089:. Food and Drug Administration. 6078: 6048: 5992: 5965: 5943: 5921: 5895: 5783: 5765: 5726: 5613:. Food and Drug Administration. 5555:. Food and Drug Administration. 5335:. Food and Drug Administration. 5111:10.1097/00129334-200501000-00003 4851:. Food and Drug Administration. 4795:. Food and Drug Administration. 4558:. Food and Drug Administration. 4509:from the original on May 9, 2017 3687:. Food and Drug Administration. 2875:. Food and Drug Administration. 2789:. Food and Drug Administration. 2603:Therapeutic Goods Administration 2566:Investigational Device Exemption 2523:Biosecurity in the United States 2488: 2476: 2464: 2452: 2361:Abbreviated New Drug Application 2180:The widely publicized recall of 2148:in 1978, creating a program for 2067:Abbreviated New Drug Application 1715:Santa Fe Natural Tobacco Company 1663:bovine spongiform encephalopathy 1576: 1441: 1339: 1195:Abbreviated New Drug Application 1183: 1065: 978: 916:Biosecurity in the United States 552:Office of External Affairs (OEA) 54: 9207:Quality Assurance International 9114:Food safety incidents in Taiwan 9084:2017 Brazil Operation Weak Meat 8978:1971 Iraq poison grain disaster 8893:Polycyclic aromatic hydrocarbon 6911:Journal of Public Health Policy 6030:"The Rise and Fall of Laetrile" 5689: 5629: 5602: 5571: 5457: 5433: 5403: 5377: 5351: 5324: 5292: 5222: 5186: 5156: 5126: 4995: 4962: 4932: 4902: 4874:Koppel N (September 12, 2011). 4867: 4841: 4811: 4785: 4744: 4714: 4653: 4604: 4574: 4548: 4522: 4495: 4403: 4354: 4295: 4265: 4233: 4203: 4174: 4148: 4047: 4012: 3934: 3925: 3895: 3850: 3841: 3806: 3776: 3738: 3703: 3677: 3651: 3621: 3562: 3532: 3506: 3476: 3449: 3419: 3384: 3357: 3326: 3296: 3269: 3239: 3208: 3175: 3118: 3087: 3057: 3027: 2949: 2093:in the 1990s and 2000s. Though 1742:American Advertising Federation 1630:Cosmetics are regulated by the 1587:needs additional citations for 1559:"FDA-Cleared" vs "FDA-Approved" 1452:needs additional citations for 1350:needs additional citations for 1153:post-market safety surveillance 1139:Post-market safety surveillance 1076:needs additional citations for 989:needs additional citations for 816:Drug Enforcement Administration 734:Federal Bureau of Investigation 635:General Services Administration 604: 202:, Principal Deputy Commissioner 18:US Food and Drug Administration 9236:European Food Safety Authority 9109:Food safety incidents in China 8946:1858 Bradford sweets poisoning 8913:Water fluoridation controversy 7983:Contract research organization 7768:Office of Refugee Resettlement 7543:Commissioner of Food and Drugs 7325:Title 21 regulations and rules 7311:Prescription Drug User Fee Act 7251:Center for Veterinary Medicine 6756:"Food and Drug Administration" 4726:Center for Veterinary Medicine 4021:Journal of Clinical Lipidology 2920: 2894: 2844:"White Oak Campus Information" 2805: 2779: 2724: 2704: 2435:companies in Washington, D.C. 1949:Pure Food and Drug Act of 1906 1891:U.S. Department of Agriculture 1812:ingredients (GC 2013-01-10)." 1771:In June 2004, the FDA cleared 1759:Regulation of living organisms 1719:Washington, D.C. federal court 1659:Center for Veterinary Medicine 1291:Coronavirus (COVID-19) testing 936: 902:Medical countermeasures (MCMs) 785: 663:Center for Veterinary Medicine 578:Office of Women's Health (OWH) 535:Center for Veterinary Medicine 407:Commissioner of Food and Drugs 252:Center for Veterinary Medicine 13: 1: 7732:National Institutes of Health 7678:Office of the Surgeon General 7306:Food Safety Modernization Act 7069:Obenchain J, Spark A (2016). 6983:. New York: Alfred A. Knopf. 6923:10.1057/palgrave.jphp.3200032 6663:"Mobile Medical Applications" 5061:"FDA_K033391_ClearanceLetter" 4969:Esterl M (November 8, 2011). 3976:Journal of Medical Toxicology 3857:Weinmeyer R (November 2013). 3182:LaMattina J (June 28, 2018). 3157:"Fact Sheet: FDA at a Glance" 2813:"Robert M. Califf M.D., MACC" 2717: 2281:Priority review voucher (PRV) 2099:Compassionate Use Act of 1996 1992:Congress of the United States 1919:Biologics Control Act of 1902 1839:Science and research programs 1427:National Institutes of Health 1421:. Along with these Acts, the 1408:Biologics License Application 1311:personal protective equipment 820:Customs and Border Protection 459:and the Office of Regulatory 9416:Food and Drug Administration 9241:Food and Drug Administration 8923:Food contamination incidents 7946:Food and Drug Administration 7717:Food and Drug Administration 7208:Food and Drug Administration 7139:Food and Drug Administration 6789:. National Academies Press. 6573:. Public Law. July 9, 2012. 5955:Food and Drug Administration 5933:Food and Drug Administration 5671:Food and Drug Administration 5609:Office of the Commissioner. 5331:Office of the Commissioner. 4379:10.1016/j.drudis.2020.11.025 4277:Food and Drug Administration 3710:Van Loo R (August 1, 2018). 3685:"New Drug Application (NDA)" 3276:Gottlieb S (June 19, 2018). 2761:"FY 2022 FDA Budget Request" 2676:Food and Drug Administration 2568:(for use in clinical trials) 2392: 2040:Outside of the US, the drug 1929:who had contracted tetanus. 1796:and Canadian Prime Minister 1792:In February 2011, President 1567: 830:Food and dietary supplements 700:Office of Regulatory Affairs 694:Office of Regulatory Affairs 639:Washington metropolitan area 544:Office of Regulatory Affairs 480:Food and Drug Administration 442:United States Virgin Islands 298:Food and Drug Administration 267:Office of Regulatory Affairs 49:Food and Drug Administration 27:United States federal agency 7: 9295:Food and drink prohibitions 9069:Bihar school meal poisoning 8993:United Kingdom BSE outbreak 8951:1900 English beer poisoning 8305:Antibiotic use in livestock 8037:The Billion-Dollar Molecule 7978:Clinical research associate 7807:National Toxicology Program 7641:Office of Inspector General 7598:Hubert H. Humphrey Building 7246:Center for Tobacco Products 5974:Canadian Journal of History 5903:"ACT UP/NY Chronology 1988" 5553:"FDA History — Part I" 3813:Van Loo R (April 1, 2020). 3751:, Oxford University Press, 3308:unblock.federalregister.gov 3035:"FDA White Oak Master Plan" 2438: 2373:mobile medical applications 2367:Mobile medical applications 2315:Rules for generic biologics 2295:neglected tropical diseases 2108:on June 8, 2017, to remove 2095:Virginia passed legislation 1899:Copyright and Patent Clause 1499:FDA Building 62 houses the 1317:and other medical devices. 1307:emergency use authorization 945:FDA Building 51 houses the 685:The Arkansas Laboratory in 661:(CBER) and offices for the 596:FDA Building 66 houses the 587: 529:Center for Tobacco Products 455:FDA Building 31 houses the 247:Center for Tobacco Products 10: 9457: 9290:Curing (food preservation) 8363:Monosodium glutamate (MSG) 6336:Retrieved August 30, 2012. 6087:"Critical Path Initiative" 5705:Independent Policy Reports 5696:Hamowy R (February 2010). 4700:10.1016/j.cvsm.2013.04.001 4302:Kliff S (August 3, 2014). 4181:Saling J (March 5, 2024). 4033:10.1016/j.jacl.2016.10.007 3633:Homeland Preparedness News 3126:"Buildings and Facilities" 2957:"Buildings and Facilities" 2732:"FDA Centennial 1906–2006" 2396: 2341:enzyme replacement therapy 2016:food standards of identity 1954:United States Pharmacopeia 1878: 1874: 1294: 1271:In 2014, the FDA added an 1176:has a REMS program called 905: 833: 738:Assistant Attorney General 647:Office of the Commissioner 485:Office of the Commissioner 457:Office of the Commissioner 29: 9426:American medical research 9333: 9320:Genetically modified food 9282: 9220: 9172:Food labeling regulations 9144: 9040:2008 Chinese milk scandal 8921: 8843: 8790: 8719: 8669: 8641: 8603: 8492: 8400: 8348: 8281: 8225: 8176:Pharmaceutical companies 8169: 8131: 8095: 8028: 7970: 7954: 7938: 7860: 7794: 7752: 7663: 7652: 7628:Secretariat staff offices 7627: 7591: 7538: 7520:FDA Most Wanted Fugitives 7507: 7371: 7355: 7343: 7331: 7324: 7296:Modernization Act of 1997 7283: 7272: 7218: 5855:How We Got Here: The '70s 5790:Temple R (October 2002). 5751:10.1017/S0007680521000726 5733:Frohlich X (March 2022). 4630:10.1080/10915810600746049 3988:10.1007/s13181-013-0374-z 3427:"What does FDA regulate?" 3247:"Inspection Observations" 3005:39.0353363°N 76.9830894°W 2787:"Animal Food & Feeds" 2683:Health Sciences Authority 2633:European Medicines Agency 2572:Kefauver Harris Amendment 2111:oxymorphone hydrochloride 2054:Kefauver-Harris Amendment 2027:Durham-Humphrey Amendment 2003:Franklin Delano Roosevelt 1921:was put in place after a 1788:International Cooperation 1525:electromagnetic radiation 1419:Public Health Service Act 1057:Advertising and promotion 933:that could require MCMs. 931:public health emergencies 812:Department of Agriculture 777:Emergency approvals (EUA) 561:Office of Operations (OO) 365:electromagnetic radiation 275: 219: 209: 183: 169: 161: 119: 109: 85: 67: 62: 53: 9182:Food safety in Australia 8378:High-fructose corn syrup 6535:10.1377/hlthaff.25.2.313 5578:cirmweb (June 4, 2012). 5506:Swann JP (Summer 2006). 4471:Carney J (May 5, 2020). 2697: 2597:African Medicines Agency 2123:Critical Path Initiative 1943:In June 1906, President 1122:Federal Trade Commission 892:food processing industry 468:Organizational structure 9162:Acceptable daily intake 9074:2013 horse meat scandal 8515:Clostridium perfringens 7988:Pharmaceutical industry 7888:Alexion Pharmaceuticals 7779:Administration on Aging 7753:Human services agencies 6477:FDA Seminar, Copenhagen 6381:. Books.nap.edu. 2007. 6235:The Wall Street Journal 6206:. Heartland Institute. 6200:Madden BJ (July 2010). 5739:Business History Review 4977:The Wall Street Journal 4883:The Wall Street Journal 3010:39.0353363; -76.9830894 2627:Danish Medicines Agency 2287:priority review voucher 2202:Congressional committee 2104:When the FDA requested 1903:Harvey Washington Wiley 1212:Mylan Laboratories Inc. 896:Polytetrafluoroethylene 631:Silver Spring, Maryland 434:Silver Spring, Maryland 369:animal foods & feed 124:Silver Spring, Maryland 99:(July 1901 – July 1927) 73:; 118 years ago 9230:Centre for Food Safety 9045:2008 Irish pork crisis 8747:Benzene in soft drinks 8077:Anatomy of an Epidemic 7913:Amylin Pharmaceuticals 7316:Pure Food and Drug Act 7012:10.1001/jama.2013.7900 6454:10.1001/jama.2011.1457 5796:Statistics in Medicine 5611:"Laws Enforced by FDA" 5417:. September 11, 2019. 4946:. September 19, 2011. 4944:Convenience Store News 4825:. September 22, 2011. 4217:. September 12, 1989. 2289:is a provision of the 2234:Pediatric drug testing 2037: 1940: 1848: 1833:transaction laundering 1504: 1398: 1246:Over-the-counter drugs 964:new molecular entities 950: 842:United States Congress 720: 690: 641:, its headquarters in 615:Prince George's County 601: 464: 405:The FDA is led by the 9252:Food Standards Agency 9202:Organic certification 9197:Nutrition facts label 8941:Esing Bakery incident 8729:environment pollution 7918:ARIAD Pharmaceuticals 7727:Indian Health Service 7665:Public Health Service 7474:Andrew von Eschenbach 7349:Federal Register (FR) 7172:The Online Books Page 6842:Bottemiller Evich H. 6604:MIT Technology Review 6600:"The Avastin Paradox" 6141:. September 9, 2016. 3580:on September 11, 2013 3484:"Dietary Supplements" 3253:. November 21, 2022. 2513:Adverse drug reaction 2410:Institute of Medicine 2260:New Drug Applications 2206:Institute of Medicine 2204:was appointed by the 2050:Frances Oldham Kelsey 2035: 1935: 1846: 1498: 1415:Biologics Control Act 1396: 1222:and in violations of 944: 906:Further information: 718: 684: 595: 454: 400:assisted reproduction 146:39.03528°N 76.98306°W 95:Bureau of Chemistry, 9021:2006 North American 8679:Acesulfame potassium 8508:Campylobacter jejuni 8402:Intestinal parasites 8275:Consumer food safety 7429:Alexander M. Schmidt 6403:on October 25, 2012. 6363:on October 23, 2012. 6279:10.1056/NEJMoa050493 6177:on February 21, 2007 5986:10.3138/cjh.44.3.467 5939:on November 1, 2013. 5236:on February 19, 2011 5170:. January 26, 2022. 4367:Drug Discovery Today 4253:on February 26, 2018 4108:. pp. 276–281. 3393:"Shaming Big Pharma" 2420:A 2022 article from 2118:21st-century reforms 2106:Endo Pharmaceuticals 1996:Elixir Sulfanilamide 1947:signed into law the 1784:to remove bacteria. 1687:U.S. Surgeon General 1596:improve this article 1537:television receivers 1461:improve this article 1359:improve this article 1303:coronavirus pandemic 1259:'s supervision like 1257:medical practitioner 1201:Generic drug scandal 1144:reports through its 1085:improve this article 1038:Trump administration 1034:new drug application 998:improve this article 926:pharmaceutical drugs 763:pharmaceutical firms 705:Federal court system 345:pharmaceutical drugs 33:FDA (disambiguation) 9325:Conspiracy theories 8878:Heterocyclic amines 8782:Shellfish poisoning 7955:Professional bodies 7873:Acorda Therapeutics 7868:Abbott Laboratories 7508:Society and culture 7444:Arthur H. Hayes Jr. 7404:Charles W. Crawford 7095:Scientific American 7033:Heartland Institute 6119:on January 25, 2018 5312:on February 9, 2019 5280:on November 8, 2014 4916:. August 18, 2011. 4417:. January 3, 2022. 3909:. January 1, 2014. 3819:Virginia Law Review 3745:Stegenga J (2018), 3716:Faculty Scholarship 3433:. October 7, 2022. 3071:. October 8, 2015. 3000: / 2585:Food Administration 2561:Inverse benefit law 2351:patients for life. 2331:, regulated by the 2329:biotechnology drugs 2321:autoimmune diseases 2155:A 2006 court case, 1887:Vaccine Act of 1813 1717:have filed suit in 1707:Commonwealth Brands 1653:Veterinary products 861:dietary supplements 772:Regulatory programs 687:Jefferson, Arkansas 396:human sperm donated 373:veterinary products 334:dietary supplements 151:39.03528; -76.98306 142: / 50: 8983:Toxic oil syndrome 8936:Swill milk scandal 8762:Diethylstilbestrol 8434:Diphyllobothriasis 8170:Related categories 7878:Adolor Corporation 7424:Charles C. Edwards 7394:Walter G. Campbell 7332:Administrative law 7027:Madden BJ (2010). 6947:David R. Henderson 6702:10.1039/C3LC51235E 6499:Widener Law Review 5643:. March 14, 2019. 5092:Sherman R (2005). 4588:. August 2, 2018. 4215:The New York Times 3863:The Virtual Mentor 2963:. April 27, 2020. 2908:on August 10, 2010 2144:ruled in favor of 2140:was created after 2038: 1960:National Formulary 1945:Theodore Roosevelt 1941: 1849: 1774:Hirudo medicinalis 1750:U.S. Supreme Court 1677:The FDA regulates 1505: 1399: 1281:Fast Track program 1228:Par Pharmaceutical 951: 721: 691: 602: 465: 411:advice and consent 357:blood transfusions 353:biopharmaceuticals 296:The United States 86:Preceding agencies 71:June 30, 1906 48: 9403: 9402: 9310:Food preservation 9119:Foodborne illness 8671:Sugar substitutes 8424:Cryptosporidiosis 8406:parasitic disease 8320:HGH controversies 8287:food contaminants 8241: 8240: 8132:Related templates 7939:Regulatory bodies 7923:Avax Technologies 7815: 7814: 7551: 7550: 7409:George P. Larrick 7389:Charles A. Browne 7367: 7366: 7080:978-1-4398-8025-8 7050:Moore TJ (1998). 7042:978-1-934791-32-5 6979:Hilts PJ (2003). 6804:978-0-309-10304-6 6742:Aayu Technologies 6448:(14): 1595–1596. 6396:978-0-309-10304-6 6272:(11): 1092–1102. 6213:978-1-934791-32-5 6006:. June 14, 2010. 5869:978-0-465-04195-4 5802:(19): 2939–2948. 5779:on July 29, 2010. 5512:Chemical Heritage 5262:on July 29, 2013. 5216:National Archives 5140:. June 28, 2004. 4766:978-3-318-02366-4 4536:on April 22, 2019 4115:978-0-7172-8244-9 4068:10.1111/ijd.13950 3948:on April 22, 2019 3758:978-0-19-874704-8 2431:and influence of 2415:regulatory powers 2349:Gaucher's disease 2150:medical marijuana 2146:Robert C. Randall 2091:medical marijuana 2023:prescription-only 2012:fraudulent intent 1909:journalists like 1628: 1627: 1620: 1493: 1492: 1485: 1391: 1390: 1383: 1117: 1116: 1109: 1036:(NDA). Under the 1030: 1029: 1022: 756:Scope and funding 611:Montgomery County 294: 293: 184:Agency executives 16:(Redirected from 9448: 9393: 9392: 9383: 9373: 9372: 9363: 9362: 9355:Drink portal 9353: 9352: 9351: 9343: 9342: 9254:(United Kingdom) 9003:Jack in the Box 8974: 8961:Minamata disease 8873:Food irradiation 8853:4-Hydroxynonenal 8701:Sodium cyclamate 8544:Escherichia coli 8536:Escherichia coli 8268: 8261: 8254: 8245: 8244: 8231: 8230: 7854: 7853: 7842: 7835: 7828: 7819: 7818: 7658: 7657: 7578: 7571: 7564: 7555: 7554: 7479:Margaret Hamburg 7454:David A. Kessler 7414:James L. Goddard 7329: 7328: 7278: 7277: 7201: 7194: 7187: 7178: 7177: 7164: 7143:Federal Register 7135: 7130: 7129: 7127:Official website 7113: 7084: 7065: 7046: 7023: 6994: 6960: 6955:(1st ed.). 6934: 6895: 6894: 6892: 6890: 6870: 6864: 6863: 6861: 6859: 6839: 6833: 6832: 6826: 6822: 6820: 6812: 6811:on July 2, 2010. 6807:. 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Alsberg 7379:Harvey W. Wiley 7363: 7351: 7344:Federal journal 7339: 7320: 7279: 7275: 7270: 7214: 7205: 7125: 7124: 7121: 7116: 7081: 7062: 7043: 7031:. 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The Paypers. 5357: 5356: 5352: 5342: 5340: 5329: 5325: 5315: 5313: 5298: 5297: 5293: 5283: 5281: 5272: 5271: 5267: 5254: 5253: 5249: 5239: 5237: 5228: 5227: 5223: 5209: 5207: 5192: 5191: 5187: 5177: 5175: 5162: 5161: 5157: 5147: 5145: 5132: 5131: 5127: 5090: 5086: 5076: 5074: 5070: 5063: 5059: 5058: 5054: 5044: 5042: 5033: 5032: 5028: 5018: 5016: 5001: 5000: 4996: 4986: 4984: 4967: 4963: 4953: 4951: 4938: 4937: 4933: 4923: 4921: 4908: 4907: 4903: 4893: 4891: 4872: 4868: 4858: 4856: 4847: 4846: 4842: 4832: 4830: 4817: 4816: 4812: 4802: 4800: 4791: 4790: 4786: 4776: 4774: 4767: 4749: 4745: 4735: 4733: 4720: 4719: 4715: 4684: 4680: 4670: 4668: 4659: 4658: 4654: 4611:Ross G (2006). 4609: 4605: 4595: 4593: 4580: 4579: 4575: 4565: 4563: 4554: 4553: 4549: 4539: 4537: 4528: 4527: 4523: 4512: 4510: 4501: 4500: 4496: 4486: 4484: 4469: 4465: 4451: 4449: 4438: 4434: 4424: 4422: 4409: 4408: 4404: 4359: 4355: 4345: 4343: 4334: 4333: 4329: 4319: 4317: 4300: 4296: 4286: 4284: 4283:on May 12, 2009 4271: 4270: 4266: 4256: 4254: 4250: 4243: 4239: 4238: 4234: 4224: 4222: 4209: 4208: 4204: 4191: 4189: 4179: 4175: 4165: 4163: 4154: 4153: 4149: 4139: 4137: 4128: 4127: 4123: 4116: 4102: 4091: 4052: 4048: 4017: 4013: 3968: 3961: 3951: 3949: 3940: 3939: 3935: 3930: 3926: 3916: 3914: 3901: 3900: 3896: 3869:(11): 954–958. 3855: 3851: 3846: 3842: 3832: 3830: 3811: 3807: 3797: 3795: 3782: 3781: 3777: 3768: 3766: 3759: 3743: 3739: 3729: 3727: 3708: 3704: 3694: 3692: 3683: 3682: 3678: 3668: 3666: 3657: 3656: 3652: 3642: 3640: 3627: 3626: 3622: 3612: 3610: 3601: 3600: 3593: 3583: 3581: 3568: 3567: 3563: 3553: 3551: 3538: 3537: 3533: 3523: 3521: 3512: 3511: 3507: 3497: 3495: 3482: 3481: 3477: 3467: 3465: 3454: 3450: 3440: 3438: 3425: 3424: 3420: 3410: 3408: 3389: 3385: 3362: 3358: 3348: 3346: 3331: 3327: 3317: 3315: 3302: 3301: 3297: 3287: 3285: 3274: 3270: 3260: 3258: 3245: 3244: 3240: 3230: 3228: 3213: 3209: 3199: 3197: 3180: 3176: 3166: 3164: 3155: 3154: 3145: 3135: 3133: 3124: 3123: 3119: 3109: 3107: 3092: 3088: 3078: 3076: 3063: 3062: 3058: 3048: 3046: 3033: 3032: 3028: 3015: 3013: 3009: 3007: 3003: 3002: 2999: 2994: 2991: 2989: 2987: 2986: 2984: 2980: 2970: 2968: 2955: 2954: 2950: 2937: 2935: 2926: 2925: 2921: 2911: 2909: 2900: 2899: 2895: 2885: 2883: 2879: 2872: 2868: 2867: 2863: 2853: 2851: 2842: 2841: 2832: 2822: 2820: 2811: 2810: 2806: 2796: 2794: 2785: 2784: 2780: 2770: 2768: 2759: 2758: 2751: 2741: 2739: 2738:on May 24, 2016 2730: 2729: 2725: 2720: 2715: 2714: 2709: 2705: 2700: 2595:African Union: 2499: 2489: 2487: 2475: 2465: 2463: 2451: 2443: 2441: 2405: 2401: 2395: 2382: 2369: 2317: 2299:Duke University 2283: 2252:legal liability 2236: 2178: 2142:Randall v. U.S. 2134: 2125: 2120: 2071:pharmacokinetic 1937:Harvey W. Wiley 1915:Progressive Era 1883: 1877: 1865: 1863:Data management 1841: 1790: 1765:medical maggots 1761: 1730:First Amendment 1675: 1655: 1624: 1613: 1607: 1604: 1593: 1581: 1570: 1561: 1541:microwave ovens 1529:cellular phones 1513:medical devices 1489: 1478: 1472: 1469: 1458: 1446: 1435: 1387: 1376: 1370: 1367: 1356: 1344: 1333: 1299: 1293: 1269: 1267:Ebola treatment 1248: 1203: 1186: 1157:clinical trials 1141: 1113: 1102: 1096: 1093: 1082: 1070: 1059: 1026: 1015: 1009: 1006: 995: 983: 972: 970:New medications 939: 918: 904: 888: 838: 832: 788: 779: 774: 758: 750: 748:Other locations 713: 696: 679: 677:Field locations 633:. In 2001, the 623: 607: 590: 585: 470: 388:cellular phones 361:medical devices 347:(medications), 279: 271: 205: 200:Namandjé Bumpus 176: 173: 150: 148: 144: 141: 136: 133: 131: 129: 128: 127: 105: 77: 75: 72: 63:Agency overview 44: 37: 30: 28: 23: 22: 15: 12: 11: 5: 9454: 9444: 9443: 9438: 9433: 9428: 9423: 9418: 9401: 9400: 9398: 9397: 9387: 9377: 9367: 9357: 9334: 9331: 9330: 9328: 9327: 9322: 9317: 9312: 9307: 9302: 9300:Food marketing 9297: 9292: 9286: 9284: 9283:Related topics 9280: 9279: 9277: 9276: 9271: 9265: 9260: 9255: 9249: 9243: 9238: 9233: 9226: 9224: 9218: 9217: 9215: 9214: 9209: 9204: 9199: 9194: 9189: 9184: 9179: 9174: 9169: 9164: 9158: 9156: 9142: 9141: 9139: 9138: 9137: 9136: 9131: 9126: 9116: 9111: 9106: 9101: 9096: 9091: 9086: 9081: 9076: 9071: 9066: 9061: 9052: 9047: 9042: 9037: 9032: 9027: 9018: 9009: 9000: 8995: 8990: 8985: 8980: 8975: 8963: 8958: 8953: 8948: 8943: 8938: 8933: 8927: 8925: 8919: 8918: 8916: 8915: 8910: 8905: 8900: 8895: 8890: 8885: 8880: 8875: 8870: 8868:Food additives 8865: 8860: 8855: 8849: 8847: 8841: 8840: 8838: 8837: 8832: 8827: 8822: 8817: 8812: 8807: 8802: 8796: 8794: 8788: 8787: 8785: 8784: 8779: 8774: 8769: 8764: 8759: 8754: 8749: 8744: 8739: 8733: 8731: 8717: 8716: 8714: 8713: 8708: 8703: 8698: 8693: 8692: 8691: 8681: 8675: 8673: 8667: 8666: 8664: 8663: 8658: 8653: 8647: 8645: 8639: 8638: 8636: 8635: 8630: 8625: 8620: 8615: 8609: 8607: 8601: 8600: 8598: 8597: 8590: 8582: 8575: 8570: 8565: 8558: 8553: 8548: 8540: 8532: 8525: 8518: 8511: 8504: 8498: 8496: 8494:Microorganisms 8490: 8489: 8487: 8486: 8481: 8476: 8471: 8466: 8464:Paragonimiasis 8461: 8456: 8451: 8446: 8441: 8436: 8431: 8429:Cyclosporiasis 8426: 8421: 8416: 8410: 8408: 8398: 8397: 8395: 8394: 8393: 8392: 8382: 8381: 8380: 8370: 8365: 8360: 8354: 8352: 8350:Food additives 8346: 8345: 8343: 8342: 8337: 8332: 8327: 8325:Lead poisoning 8322: 8317: 8312: 8307: 8302: 8297: 8291: 8289: 8279: 8278: 8271: 8270: 8263: 8256: 8248: 8239: 8238: 8226: 8223: 8222: 8220: 8219: 8218: 8217: 8212: 8210:United Kingdom 8207: 8202: 8197: 8192: 8187: 8182: 8173: 8171: 8167: 8166: 8164: 8163: 8158: 8157: 8156: 8151: 8149:United Kingdom 8141: 8135: 8133: 8129: 8128: 8126: 8125: 8120: 8115: 8110: 8105: 8103:Lists of drugs 8099: 8097: 8093: 8092: 8090: 8089: 8081: 8073: 8065: 8057: 8049: 8045:Mad in America 8041: 8032: 8030: 8026: 8025: 8023: 8022: 8017: 8016: 8015: 8013:United Kingdom 8010: 8005: 8000: 7995: 7985: 7980: 7974: 7972: 7968: 7967: 7965: 7964: 7958: 7956: 7952: 7951: 7949: 7948: 7942: 7940: 7936: 7935: 7933: 7932: 7925: 7920: 7915: 7910: 7905: 7900: 7895: 7890: 7885: 7880: 7875: 7870: 7864: 7862: 7858: 7857: 7845: 7844: 7837: 7830: 7822: 7813: 7812: 7810: 7809: 7804: 7798: 7796: 7792: 7791: 7789: 7788: 7783: 7782: 7781: 7771: 7756: 7754: 7750: 7749: 7747: 7746: 7745: 7744: 7734: 7729: 7724: 7719: 7714: 7713: 7712: 7707: 7702: 7692: 7687: 7686: 7685: 7680: 7669: 7667: 7661: 7660: 7653: 7651: 7649: 7648: 7643: 7638: 7635: 7631: 7629: 7625: 7624: 7622: 7621: 7612: 7606:Xavier Becerra 7602: 7601: 7595:Headquarters: 7592: 7589: 7588: 7581: 7580: 7573: 7566: 7558: 7549: 7548: 7546: 7545: 7539: 7536: 7535: 7533: 7532: 7527: 7522: 7517: 7511: 7509: 7505: 7504: 7502: 7501: 7496: 7491: 7489:Scott Gottlieb 7486: 7481: 7476: 7471: 7466: 7464:Mark McClellan 7461: 7459:Jane E. Henney 7456: 7451: 7449:Frank E. Young 7446: 7441: 7436: 7434:Donald Kennedy 7431: 7426: 7421: 7419:Herbert L. Ley 7416: 7411: 7406: 7401: 7399:Paul B. Dunbar 7396: 7391: 7386: 7381: 7375: 7373: 7369: 7368: 7365: 7364: 7359: 7357: 7353: 7352: 7347: 7345: 7341: 7340: 7335: 7333: 7326: 7322: 7321: 7319: 7318: 7313: 7308: 7303: 7298: 7293: 7287: 7285: 7281: 7280: 7273: 7271: 7269: 7268: 7263: 7258: 7253: 7248: 7243: 7238: 7233: 7228: 7222: 7220: 7216: 7215: 7204: 7203: 7196: 7189: 7181: 7175: 7174: 7165: 7151: 7148:Strategic Plan 7145: 7136: 7120: 7119:External links 7117: 7115: 7114: 7086: 7079: 7066: 7060: 7047: 7041: 7024: 6995: 6989: 6976: 6935: 6917:(4): 450–468. 6905: 6903: 6900: 6897: 6896: 6865: 6834: 6803: 6795:10.17226/11750 6775: 6761: 6747: 6738:"AS2 Protocol" 6729: 6715: 6696:(5): 833–840. 6680: 6654: 6621: 6591: 6559: 6528:(2): 313–324. 6522:Health Affairs 6508: 6482: 6467: 6432: 6406: 6395: 6387:10.17226/11750 6366: 6338: 6334:(28.3 KB) 6301: 6252: 6219: 6212: 6192: 6156: 6130: 6104: 6077: 6047: 6021: 5991: 5980:(3): 467–488. 5964: 5942: 5920: 5894: 5875: 5868: 5841: 5782: 5764: 5745:(1): 145–176. 5725: 5688: 5658: 5628: 5601: 5570: 5533: 5485: 5456: 5432: 5402: 5376: 5350: 5323: 5291: 5265: 5247: 5221: 5199:whitehouse.gov 5185: 5155: 5125: 5084: 5052: 5026: 4994: 4961: 4931: 4901: 4866: 4840: 4810: 4784: 4765: 4743: 4713: 4678: 4652: 4623:(4): 269–277. 4603: 4573: 4547: 4521: 4494: 4463: 4432: 4402: 4373:(2): 593–603. 4353: 4327: 4294: 4264: 4232: 4202: 4173: 4147: 4121: 4114: 4089: 4046: 4011: 3982:(2): 165–172. 3959: 3933: 3924: 3894: 3849: 3840: 3805: 3775: 3757: 3737: 3702: 3676: 3650: 3620: 3591: 3561: 3531: 3505: 3475: 3448: 3418: 3383: 3356: 3325: 3295: 3268: 3238: 3207: 3174: 3143: 3117: 3086: 3056: 3026: 2978: 2948: 2919: 2893: 2870:"FDA Overview" 2861: 2830: 2804: 2778: 2749: 2722: 2721: 2719: 2716: 2713: 2712: 2702: 2701: 2699: 2696: 2695: 2694: 2691: 2685: 2679: 2672: 2666: 2660: 2653: 2647: 2641: 2635: 2629: 2623: 2617: 2611: 2605: 2599: 2593: 2587: 2579:International: 2576: 2575: 2569: 2563: 2558: 2552: 2546: 2540: 2535: 2530: 2525: 2520: 2515: 2510: 2505: 2498: 2497: 2485: 2473: 2461: 2440: 2437: 2397:Main article: 2394: 2391: 2381: 2378: 2368: 2365: 2316: 2313: 2304:Health Affairs 2282: 2279: 2235: 2232: 2215:pharmaceutical 2177: 2174: 2133: 2130: 2124: 2121: 2119: 2116: 1970:By the 1930s, 1911:Upton Sinclair 1895:itself derived 1879:Main article: 1876: 1873: 1864: 1861: 1840: 1837: 1798:Stephen Harper 1789: 1786: 1760: 1757: 1674: 1671: 1654: 1651: 1626: 1625: 1584: 1582: 1575: 1569: 1566: 1560: 1557: 1549:laser products 1545:tanning booths 1491: 1490: 1449: 1447: 1440: 1434: 1431: 1389: 1388: 1347: 1345: 1338: 1332: 1329: 1305:, FDA granted 1295:Main article: 1292: 1289: 1268: 1265: 1247: 1244: 1202: 1199: 1185: 1182: 1140: 1137: 1115: 1114: 1073: 1071: 1064: 1058: 1055: 1028: 1027: 986: 984: 977: 971: 968: 938: 935: 903: 900: 887: 884: 857:food additives 834:Main article: 831: 828: 787: 784: 778: 775: 773: 770: 757: 754: 749: 746: 712: 709: 695: 692: 678: 675: 622: 619: 606: 603: 589: 586: 584: 583: 582: 581: 580: 579: 576: 575: 574: 565: 562: 559: 556: 553: 550: 547: 541: 538: 532: 526: 520: 514: 508: 502: 501: 500: 497: 494: 491: 471: 469: 466: 310:federal agency 292: 291: 277: 273: 272: 270: 269: 264: 259: 254: 249: 244: 239: 234: 229: 223: 221: 220:Child agencies 217: 216: 211: 207: 206: 204: 203: 197: 187: 185: 181: 180: 179:billion (2022) 171: 167: 166: 163: 159: 158: 121: 117: 116: 111: 107: 106: 104: 103: 100: 93: 89: 87: 83: 82: 69: 65: 64: 60: 59: 26: 9: 6: 4: 3: 2: 9453: 9442: 9439: 9437: 9434: 9432: 9429: 9427: 9424: 9422: 9419: 9417: 9414: 9413: 9411: 9396: 9388: 9386: 9382: 9378: 9376: 9368: 9366: 9358: 9356: 9346: 9341: 9336: 9335: 9332: 9326: 9323: 9321: 9318: 9316: 9313: 9311: 9308: 9306: 9305:Food politics 9303: 9301: 9298: 9296: 9293: 9291: 9288: 9287: 9285: 9281: 9275: 9272: 9270:(South Korea) 9269: 9266: 9264: 9261: 9259: 9256: 9253: 9250: 9247: 9244: 9242: 9239: 9237: 9234: 9231: 9228: 9227: 9225: 9223: 9219: 9213: 9210: 9208: 9205: 9203: 9200: 9198: 9195: 9193: 9190: 9188: 9185: 9183: 9180: 9178: 9175: 9173: 9170: 9168: 9165: 9163: 9160: 9159: 9157: 9155: 9151: 9147: 9143: 9135: 9134:United States 9132: 9130: 9127: 9125: 9122: 9121: 9120: 9117: 9115: 9112: 9110: 9107: 9105: 9102: 9100: 9097: 9095: 9092: 9090: 9087: 9085: 9082: 9080: 9077: 9075: 9072: 9070: 9067: 9065: 9062: 9060: 9058: 9055:2011 Germany 9053: 9051: 9048: 9046: 9043: 9041: 9038: 9036: 9033: 9031: 9028: 9026: 9024: 9019: 9017: 9015: 9012:1996 Odwalla 9010: 9008: 9006: 9001: 8999: 8996: 8994: 8991: 8989: 8986: 8984: 8981: 8979: 8976: 8972: 8967: 8964: 8962: 8959: 8957: 8954: 8952: 8949: 8947: 8944: 8942: 8939: 8937: 8934: 8932: 8929: 8928: 8926: 8924: 8920: 8914: 8911: 8909: 8906: 8904: 8901: 8899: 8896: 8894: 8891: 8889: 8886: 8884: 8881: 8879: 8876: 8874: 8871: 8869: 8866: 8864: 8861: 8859: 8856: 8854: 8851: 8850: 8848: 8846: 8842: 8836: 8833: 8831: 8828: 8826: 8823: 8821: 8818: 8816: 8813: 8811: 8808: 8806: 8803: 8801: 8798: 8797: 8795: 8793: 8789: 8783: 8780: 8778: 8775: 8773: 8770: 8768: 8765: 8763: 8760: 8758: 8755: 8753: 8750: 8748: 8745: 8743: 8740: 8738: 8735: 8734: 8732: 8730: 8726: 8722: 8718: 8712: 8709: 8707: 8704: 8702: 8699: 8697: 8694: 8690: 8687: 8686: 8685: 8682: 8680: 8677: 8676: 8674: 8672: 8668: 8662: 8659: 8657: 8654: 8652: 8649: 8648: 8646: 8644: 8643:Preservatives 8640: 8634: 8633:Methamidophos 8631: 8629: 8626: 8624: 8621: 8619: 8616: 8614: 8611: 8610: 8608: 8606: 8602: 8596: 8595: 8591: 8589: 8588: 8583: 8581: 8580: 8576: 8574: 8571: 8569: 8566: 8564: 8563: 8559: 8557: 8554: 8552: 8549: 8547: 8545: 8541: 8539: 8537: 8533: 8531: 8530: 8526: 8524: 8523: 8519: 8517: 8516: 8512: 8510: 8509: 8505: 8503: 8500: 8499: 8497: 8495: 8491: 8485: 8482: 8480: 8477: 8475: 8474:Toxoplasmosis 8472: 8470: 8467: 8465: 8462: 8460: 8457: 8455: 8452: 8450: 8447: 8445: 8442: 8440: 8437: 8435: 8432: 8430: 8427: 8425: 8422: 8420: 8417: 8415: 8412: 8411: 8409: 8407: 8403: 8399: 8391: 8388: 8387: 8386: 8385:Vegetable oil 8383: 8379: 8376: 8375: 8374: 8371: 8369: 8366: 8364: 8361: 8359: 8356: 8355: 8353: 8351: 8347: 8341: 8338: 8336: 8333: 8331: 8328: 8326: 8323: 8321: 8318: 8316: 8313: 8311: 8308: 8306: 8303: 8301: 8298: 8296: 8293: 8292: 8290: 8288: 8284: 8280: 8276: 8269: 8264: 8262: 8257: 8255: 8250: 8249: 8246: 8236: 8235: 8224: 8216: 8215:United States 8213: 8211: 8208: 8206: 8203: 8201: 8198: 8196: 8193: 8191: 8188: 8186: 8183: 8181: 8178: 8177: 8175: 8174: 8172: 8168: 8162: 8161:Public health 8159: 8155: 8154:United States 8152: 8150: 8147: 8146: 8145: 8142: 8140: 8137: 8136: 8134: 8130: 8124: 8121: 8119: 8116: 8114: 8111: 8109: 8106: 8104: 8101: 8100: 8098: 8094: 8087: 8086: 8082: 8079: 8078: 8074: 8071: 8070: 8066: 8063: 8062: 8058: 8055: 8054: 8050: 8047: 8046: 8042: 8039: 8038: 8034: 8033: 8031: 8027: 8021: 8018: 8014: 8011: 8009: 8006: 8004: 8001: 7999: 7996: 7994: 7991: 7990: 7989: 7986: 7984: 7981: 7979: 7976: 7975: 7973: 7971:Miscellaneous 7969: 7963: 7960: 7959: 7957: 7953: 7947: 7944: 7943: 7941: 7937: 7931: 7930: 7926: 7924: 7921: 7919: 7916: 7914: 7911: 7909: 7906: 7904: 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Goyan 7437: 7435: 7432: 7430: 7427: 7425: 7422: 7420: 7417: 7415: 7412: 7410: 7407: 7405: 7402: 7400: 7397: 7395: 7392: 7390: 7387: 7385: 7382: 7380: 7377: 7376: 7374: 7372:Commissioners 7370: 7362: 7358: 7354: 7350: 7346: 7342: 7338: 7334: 7330: 7327: 7323: 7317: 7314: 7312: 7309: 7307: 7304: 7302: 7299: 7297: 7294: 7292: 7289: 7288: 7286: 7282: 7267: 7264: 7262: 7259: 7257: 7254: 7252: 7249: 7247: 7244: 7242: 7239: 7237: 7234: 7232: 7229: 7227: 7224: 7223: 7221: 7217: 7213: 7212:United States 7209: 7202: 7197: 7195: 7190: 7188: 7183: 7182: 7179: 7173: 7169: 7166: 7163: 7159: 7155: 7152: 7149: 7146: 7144: 7140: 7137: 7134: 7128: 7123: 7122: 7112: 7108: 7104: 7100: 7096: 7092: 7087: 7082: 7076: 7072: 7067: 7063: 7061:0-684-82998-3 7057: 7053: 7048: 7044: 7038: 7034: 7030: 7025: 7021: 7017: 7013: 7009: 7005: 7001: 6996: 6992: 6990:0-375-40466-X 6986: 6982: 6977: 6975: 6971: 6967: 6963: 6958: 6954: 6953: 6948: 6944: 6940: 6936: 6932: 6928: 6924: 6920: 6916: 6912: 6907: 6906: 6884: 6881:. Food Dive. 6880: 6876: 6869: 6853: 6849: 6845: 6838: 6830: 6818: 6810: 6806: 6800: 6796: 6792: 6788: 6787: 6779: 6771: 6765: 6757: 6751: 6743: 6739: 6733: 6725: 6719: 6711: 6707: 6703: 6699: 6695: 6691: 6690:Lab on a Chip 6684: 6668: 6664: 6658: 6642: 6638: 6634: 6628: 6626: 6609: 6605: 6601: 6595: 6576: 6569: 6563: 6555: 6551: 6546: 6541: 6536: 6531: 6527: 6523: 6519: 6512: 6504: 6500: 6493: 6491: 6489: 6487: 6478: 6471: 6463: 6459: 6455: 6451: 6447: 6443: 6436: 6420: 6416: 6410: 6402: 6398: 6392: 6388: 6384: 6380: 6376: 6370: 6362: 6358: 6357: 6352: 6345: 6343: 6318: 6311: 6305: 6297: 6293: 6289: 6285: 6280: 6275: 6271: 6267: 6263: 6256: 6240: 6236: 6231: 6223: 6215: 6209: 6205: 6204: 6196: 6189:(119 KB) 6173: 6166: 6160: 6144: 6140: 6134: 6118: 6114: 6108: 6092: 6088: 6081: 6074: 6061: 6057: 6051: 6035: 6031: 6025: 6009: 6005: 6001: 5995: 5987: 5983: 5979: 5975: 5968: 5960: 5956: 5952: 5946: 5938: 5934: 5930: 5924: 5908: 5904: 5898: 5890: 5886: 5879: 5871: 5865: 5861: 5857: 5856: 5851: 5845: 5829: 5825: 5821: 5817: 5813: 5809: 5805: 5801: 5797: 5793: 5786: 5778: 5774: 5768: 5760: 5756: 5752: 5748: 5744: 5740: 5736: 5729: 5710: 5706: 5699: 5692: 5676: 5672: 5668: 5662: 5646: 5642: 5638: 5632: 5616: 5612: 5605: 5589: 5585: 5581: 5574: 5558: 5554: 5548: 5546: 5544: 5542: 5540: 5538: 5526:September 17, 5521: 5517: 5513: 5509: 5502: 5500: 5498: 5496: 5494: 5492: 5490: 5473: 5469: 5468: 5460: 5452: 5448: 5447: 5442: 5436: 5420: 5416: 5412: 5406: 5390: 5386: 5380: 5364: 5360: 5354: 5338: 5334: 5327: 5311: 5307: 5306: 5301: 5295: 5279: 5275: 5269: 5261: 5257: 5251: 5235: 5231: 5225: 5217: 5205: 5201: 5200: 5195: 5189: 5173: 5169: 5165: 5159: 5143: 5139: 5135: 5129: 5121: 5117: 5112: 5107: 5103: 5099: 5095: 5088: 5069: 5062: 5056: 5040: 5036: 5030: 5014: 5010: 5009: 5004: 4998: 4982: 4978: 4973: 4965: 4949: 4945: 4941: 4935: 4919: 4915: 4911: 4905: 4889: 4885: 4884: 4878: 4870: 4854: 4850: 4844: 4828: 4824: 4820: 4814: 4798: 4794: 4788: 4772: 4768: 4762: 4758: 4754: 4747: 4731: 4727: 4723: 4717: 4709: 4705: 4701: 4697: 4693: 4689: 4682: 4666: 4662: 4656: 4648: 4644: 4640: 4636: 4631: 4626: 4622: 4618: 4614: 4607: 4591: 4587: 4583: 4577: 4561: 4557: 4551: 4535: 4531: 4525: 4508: 4504: 4498: 4482: 4478: 4474: 4467: 4460: 4447: 4443: 4436: 4420: 4416: 4412: 4406: 4398: 4394: 4389: 4384: 4380: 4376: 4372: 4368: 4364: 4357: 4341: 4337: 4331: 4315: 4311: 4310: 4305: 4298: 4282: 4278: 4274: 4268: 4249: 4242: 4236: 4220: 4216: 4212: 4206: 4199: 4188: 4184: 4177: 4161: 4157: 4151: 4135: 4131: 4125: 4117: 4111: 4107: 4100: 4098: 4096: 4094: 4085: 4081: 4077: 4073: 4069: 4065: 4061: 4057: 4050: 4042: 4038: 4034: 4030: 4026: 4022: 4015: 4007: 4003: 3998: 3993: 3989: 3985: 3981: 3977: 3973: 3966: 3964: 3947: 3943: 3937: 3928: 3912: 3908: 3904: 3898: 3890: 3886: 3882: 3877: 3872: 3868: 3864: 3860: 3853: 3844: 3828: 3824: 3820: 3816: 3809: 3793: 3789: 3785: 3779: 3764: 3760: 3754: 3750: 3749: 3741: 3725: 3721: 3717: 3713: 3706: 3690: 3686: 3680: 3664: 3660: 3654: 3638: 3634: 3630: 3624: 3608: 3604: 3598: 3596: 3579: 3575: 3571: 3565: 3549: 3545: 3541: 3535: 3519: 3515: 3509: 3493: 3489: 3485: 3479: 3463: 3459: 3452: 3436: 3432: 3428: 3422: 3406: 3402: 3398: 3394: 3387: 3379: 3375: 3371: 3367: 3360: 3344: 3340: 3336: 3329: 3313: 3309: 3305: 3299: 3283: 3279: 3272: 3256: 3252: 3248: 3242: 3231:September 10, 3226: 3222: 3218: 3211: 3195: 3191: 3190: 3185: 3178: 3162: 3158: 3152: 3150: 3148: 3131: 3127: 3121: 3105: 3101: 3097: 3090: 3074: 3070: 3066: 3060: 3044: 3040: 3036: 3030: 3022: 2982: 2966: 2962: 2958: 2952: 2945: 2933: 2929: 2923: 2907: 2903: 2897: 2878: 2871: 2865: 2849: 2845: 2839: 2837: 2835: 2818: 2814: 2808: 2792: 2788: 2782: 2766: 2762: 2756: 2754: 2742:September 13, 2737: 2733: 2727: 2723: 2707: 2703: 2692: 2690: 2686: 2684: 2680: 2677: 2674:Philippines: 2673: 2671: 2667: 2665: 2661: 2658: 2654: 2652: 2648: 2646: 2642: 2640: 2636: 2634: 2630: 2628: 2624: 2622: 2621:Health Canada 2618: 2616: 2612: 2610: 2606: 2604: 2600: 2598: 2594: 2591: 2588: 2586: 2583: 2582: 2581: 2580: 2573: 2570: 2567: 2564: 2562: 2559: 2556: 2553: 2550: 2547: 2544: 2541: 2539: 2536: 2534: 2531: 2529: 2526: 2524: 2521: 2519: 2516: 2514: 2511: 2509: 2508:Adverse event 2506: 2504: 2501: 2500: 2496: 2486: 2484: 2479: 2474: 2472: 2471:United States 2462: 2460: 2455: 2450: 2449: 2446: 2436: 2434: 2430: 2425: 2424: 2418: 2416: 2411: 2408:million 2006 2400: 2390: 2386: 2377: 2374: 2364: 2362: 2358: 2352: 2350: 2346: 2342: 2338: 2334: 2330: 2326: 2322: 2312: 2310: 2306: 2305: 2300: 2296: 2292: 2288: 2278: 2276: 2272: 2268: 2263: 2261: 2255: 2253: 2249: 2244: 2241: 2240:pediatricians 2231: 2227: 2225: 2220: 2216: 2212: 2211:biostatistics 2207: 2203: 2198: 2194: 2191: 2190:heart attacks 2187: 2183: 2173: 2170: 2166: 2164: 2160: 2159: 2153: 2151: 2147: 2143: 2139: 2129: 2115: 2113: 2112: 2107: 2102: 2100: 2096: 2092: 2088: 2082: 2079: 2074: 2072: 2068: 2064: 2058: 2055: 2051: 2047: 2043: 2034: 2030: 2028: 2024: 2019: 2017: 2013: 2008: 2004: 1999: 1997: 1993: 1989: 1985: 1981: 1978: 1973: 1968: 1964: 1962: 1961: 1956: 1955: 1950: 1946: 1938: 1934: 1930: 1928: 1924: 1920: 1916: 1912: 1908: 1904: 1900: 1896: 1892: 1888: 1882: 1872: 1870: 1860: 1858: 1854: 1845: 1836: 1834: 1830: 1826: 1822: 1818: 1813: 1811: 1810:antihistamine 1807: 1806:Health Canada 1802: 1799: 1795: 1785: 1783: 1778: 1776: 1775: 1769: 1766: 1756: 1753: 1751: 1747: 1743: 1739: 1735: 1731: 1726: 1724: 1720: 1716: 1712: 1711:Liggett Group 1708: 1704: 1700: 1699:R.J. Reynolds 1696: 1690: 1688: 1684: 1680: 1670: 1668: 1664: 1660: 1650: 1646: 1644: 1639: 1637: 1636:Cosmeceutical 1633: 1622: 1619: 1611: 1601: 1597: 1591: 1590: 1585:This section 1583: 1579: 1574: 1573: 1565: 1556: 1552: 1550: 1546: 1542: 1538: 1534: 1530: 1526: 1522: 1518: 1514: 1510: 1502: 1497: 1487: 1484: 1476: 1466: 1462: 1456: 1455: 1450:This section 1448: 1444: 1439: 1438: 1430: 1428: 1424: 1420: 1416: 1411: 1409: 1404: 1395: 1385: 1382: 1374: 1364: 1360: 1354: 1353: 1348:This section 1346: 1342: 1337: 1336: 1328: 1326: 1323: 1318: 1316: 1312: 1308: 1304: 1298: 1288: 1286: 1282: 1278: 1274: 1264: 1262: 1258: 1253: 1243: 1241: 1237: 1231: 1229: 1225: 1224:antitrust law 1221: 1217: 1213: 1209: 1198: 1196: 1191: 1184:Generic drugs 1181: 1179: 1175: 1171: 1166: 1162: 1158: 1154: 1149: 1147: 1136: 1134: 1129: 1125: 1123: 1111: 1108: 1100: 1090: 1086: 1080: 1079: 1074:This section 1072: 1068: 1063: 1062: 1054: 1051: 1045: 1042: 1039: 1035: 1024: 1021: 1013: 1003: 999: 993: 992: 987:This section 985: 981: 976: 975: 967: 965: 961: 956: 948: 943: 934: 932: 927: 923: 917: 913: 909: 899: 897: 893: 883: 879: 877: 872: 870: 866: 862: 858: 853: 851: 847: 843: 837: 827: 825: 821: 817: 813: 808: 806: 800: 796: 794: 783: 769: 766: 764: 753: 745: 743: 739: 735: 731: 726: 717: 708: 706: 701: 688: 683: 674: 672: 666: 664: 660: 656: 652: 648: 644: 640: 636: 632: 628: 618: 616: 612: 599: 594: 577: 572: 569: 568: 566: 563: 560: 557: 554: 551: 548: 545: 542: 539: 536: 533: 530: 527: 524: 521: 518: 515: 512: 509: 506: 503: 498: 495: 492: 489: 488: 486: 483: 482: 481: 478: 477: 476: 473: 472: 462: 458: 453: 449: 447: 443: 439: 435: 431: 426: 424: 423:Robert Califf 420: 416: 412: 408: 403: 401: 397: 393: 389: 385: 381: 376: 374: 370: 366: 362: 358: 354: 350: 346: 343: 339: 335: 331: 327: 323: 319: 318:public health 315: 311: 307: 303: 299: 289: 284: 278: 274: 268: 265: 263: 260: 258: 255: 253: 250: 248: 245: 243: 240: 238: 235: 233: 230: 228: 225: 224: 222: 218: 215: 212: 210:Parent agency 208: 201: 198: 196: 192: 191:Robert Califf 189: 188: 186: 182: 172: 170:Annual budget 168: 165:18,000 (2022) 164: 160: 155: 125: 122: 118: 115: 112: 108: 101: 98: 94: 91: 90: 88: 84: 70: 66: 61: 57: 52: 46: 41: 34: 19: 9315:Food quality 9240: 9222:Institutions 9056: 9022: 9013: 9004: 8888:Nitrosamines 8651:Benzoic acid 8613:Chlorpyrifos 8592: 8586: 8577: 8560: 8543: 8535: 8527: 8520: 8513: 8506: 8484:Trichuriasis 8469:Toxocariasis 8439:Enterobiasis 8315:Formaldehyde 8232: 8083: 8075: 8069:Side Effects 8067: 8059: 8051: 8043: 8035: 7945: 7927: 7716: 7596: 7494:Stephen Hahn 7207: 7158:Open Library 7110: 7098: 7094: 7085:</ref> 7070: 7051: 7028: 7006:(2): 202–4. 7003: 6999: 6980: 6950: 6914: 6910: 6887:. Retrieved 6879:fooddive.com 6878: 6868: 6856:. Retrieved 6850:. Politico. 6848:politico.com 6847: 6837: 6809:the original 6785: 6778: 6764: 6750: 6741: 6732: 6718: 6693: 6689: 6683: 6671:. Retrieved 6657: 6645:. Retrieved 6636: 6612:. Retrieved 6603: 6594: 6584:November 19, 6582:. Retrieved 6562: 6525: 6521: 6511: 6502: 6498: 6476: 6470: 6445: 6441: 6435: 6423:. Retrieved 6409: 6401:the original 6378: 6369: 6361:the original 6354: 6324:. Retrieved 6304: 6269: 6265: 6255: 6243:. Retrieved 6234: 6222: 6202: 6195: 6179:. Retrieved 6172:the original 6159: 6147:. Retrieved 6133: 6121:. Retrieved 6117:the original 6107: 6097:December 16, 6095:. Retrieved 6080: 6071: 6064:. Retrieved 6050: 6038:. Retrieved 6024: 6012:. Retrieved 6003: 5994: 5977: 5973: 5967: 5959:the original 5954: 5945: 5937:the original 5932: 5923: 5911:. Retrieved 5897: 5888: 5884: 5878: 5854: 5844: 5832:. Retrieved 5799: 5795: 5785: 5777:the original 5767: 5742: 5738: 5728: 5716:. 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Retrieved 3582:. Retrieved 3578:the original 3574:DECC Company 3573: 3564: 3552:. Retrieved 3543: 3534: 3522:. Retrieved 3508: 3496:. Retrieved 3487: 3478: 3466:. Retrieved 3451: 3439:. Retrieved 3430: 3421: 3409:. Retrieved 3400: 3396: 3386: 3369: 3365: 3359: 3347:. Retrieved 3338: 3328: 3316:. Retrieved 3307: 3298: 3286:. Retrieved 3271: 3259:. Retrieved 3250: 3241: 3229:. Retrieved 3220: 3210: 3198:. Retrieved 3187: 3177: 3167:February 21, 3165:. Retrieved 3134:. Retrieved 3120: 3108:. Retrieved 3099: 3089: 3079:December 16, 3077:. Retrieved 3068: 3059: 3047:. Retrieved 3038: 3029: 2981: 2969:. Retrieved 2960: 2951: 2943: 2936:. Retrieved 2922: 2910:. Retrieved 2906:the original 2896: 2884:. Retrieved 2864: 2852:. Retrieved 2821:. Retrieved 2807: 2795:. Retrieved 2781: 2769:. Retrieved 2740:. Retrieved 2736:the original 2726: 2706: 2578: 2577: 2551:(e.g. drugs) 2421: 2419: 2402: 2387: 2383: 2370: 2353: 2318: 2302: 2284: 2264: 2256: 2245: 2237: 2228: 2199: 2195: 2179: 2167: 2156: 2154: 2141: 2135: 2126: 2109: 2103: 2083: 2075: 2059: 2039: 2020: 2000: 1988:tuberculosis 1969: 1965: 1958: 1952: 1942: 1884: 1866: 1850: 1814: 1803: 1794:Barack Obama 1791: 1779: 1772: 1770: 1762: 1754: 1746:Richard Leon 1734:Floyd Abrams 1727: 1694: 1691: 1676: 1656: 1647: 1640: 1629: 1614: 1605: 1594:Please help 1589:verification 1586: 1562: 1553: 1506: 1479: 1470: 1459:Please help 1454:verification 1451: 1412: 1400: 1377: 1368: 1357:Please help 1352:verification 1349: 1319: 1300: 1270: 1249: 1232: 1220:racketeering 1204: 1187: 1174:isotretinoin 1150: 1142: 1130: 1126: 1118: 1103: 1094: 1083:Please help 1078:verification 1075: 1046: 1041: 1031: 1016: 1007: 996:Please help 991:verification 988: 963: 952: 919: 912:Bioterrorism 889: 880: 873: 854: 839: 809: 805:generic drug 801: 797: 789: 780: 767: 759: 751: 722: 697: 667: 657:(CDRH), the 653:(CDER), the 624: 617:, Maryland. 608: 605:Headquarters 479: 438:laboratories 427: 404: 377: 338:prescription 305: 301: 297: 295: 195:Commissioner 120:Headquarters 110:Jurisdiction 45: 9395:WikiProject 9232:(Hong Kong) 8969: [ 8931:Devon colic 8805:Breast milk 8777:Nonylphenol 8752:Bisphenol A 8689:controversy 8556:Hepatitis E 8551:Hepatitis A 8529:Enterovirus 8522:Cronobacter 8479:Trichinosis 8449:Fasciolosis 8419:Anisakiasis 8390:controversy 8283:Adulterants 8205:Switzerland 7615:Andrea Palm 7356:Federal law 6939:Henninger D 6873:Doering C. 6825:|work= 6637:GovTrack.us 6149:October 14, 6066:October 26, 5718:January 14, 5594:January 14, 5518:(2): 6–11. 5478:January 14, 5369:February 8, 5343:February 8, 5316:February 8, 5178:January 14, 5148:January 14, 4833:October 13, 4736:February 4, 4671:January 21, 4596:December 4, 4425:October 27, 4225:February 7, 3917:January 14, 3833:October 25, 3798:October 23, 3730:October 10, 3669:January 14, 3584:October 23, 3441:January 14, 3349:January 14, 3318:January 14, 3261:January 14, 3110:January 14, 3096:"About OCI" 3008: / 2771:January 14, 2681:Singapore: 2601:Australia: 2545:(for drugs) 2518:Biosecurity 2200:In 2006, a 2042:thalidomide 2005:signed the 1977:radioactive 1857:impediments 1782:pasteurized 1608:August 2019 1473:August 2019 1371:August 2019 1315:ventilators 1301:During the 1165:thalidomide 1097:August 2019 1010:August 2019 937:Medications 908:Biosecurity 865:amino acids 807:companies. 786:Regulations 740:, and even 446:Puerto Rico 398:for use in 322:food safety 149: / 9410:Categories 9146:Regulation 9129:death toll 8898:Shortening 8863:Acrylamide 8792:Food fraud 8772:Mycotoxins 8605:Pesticides 8579:Salmonella 8454:Giardiasis 8414:Amoebiasis 8358:Flavorings 8085:Bad Pharma 8061:Big Pharma 7993:Bangladesh 7284:Major acts 7150:(archived) 7091:El-Sayed A 6943:"Drug Lag" 6614:January 6, 6545:10161/7017 6326:August 30, 6123:August 30, 5891:: 602–620. 5651:October 3, 5425:October 3, 4859:August 30, 4540:August 30, 4287:October 9, 4257:August 30, 4140:August 30, 3952:October 9, 3825:(2): 467. 3722:(2): 369. 3200:January 3, 3049:October 3, 3014: ( 2995:76°58′59″W 2992:39°02′07″N 2971:October 3, 2886:August 30, 2718:References 2001:President 1972:muckraking 1923:diphtheria 1907:muckraking 1517:toothbrush 1255:without a 1216:Pittsburgh 1190:name-brand 960:excipients 874:Under the 822:, and the 782:pandemic. 332:products, 328:products, 137:76°58′59″W 78:1906-06-30 9192:ISO 22000 9154:watchdogs 9150:standards 9124:outbreaks 9025:outbreaks 8903:Trans fat 8815:Olive oil 8737:Aflatoxin 8711:Sucralose 8696:Saccharin 8684:Aspartame 8628:Malathion 8573:Rotavirus 8568:Norovirus 8180:Australia 7861:Companies 7219:Divisions 7101:(1): 10. 6974:163149563 6966:317650570 6889:April 18, 6827:ignored ( 6817:cite book 6673:March 14, 6647:March 14, 6425:March 14, 6245:August 3, 6181:March 11, 6040:March 14, 6014:March 14, 5913:March 14, 5759:0007-6805 5563:March 14, 5411:"openFDA" 4987:August 3, 4954:March 14, 4924:March 14, 4894:August 4, 4566:March 14, 4320:August 4, 3769:April 20, 2912:April 10, 2823:March 20, 2797:March 14, 2637:Germany: 2625:Denmark: 2393:Criticism 1980:beverages 1897:from the 1829:antiviral 1703:Lorillard 1568:Cosmetics 1406:called a 1261:ibuprofen 1133:off-label 1131:The term 922:biologics 643:Rockville 627:White Oak 430:White Oak 162:Employees 9385:Cookbook 9365:Category 9167:E number 9059:outbreak 9016:outbreak 9007:outbreak 8757:Dieldrin 8706:Sorbitol 8562:Listeria 8502:Botulism 8330:Melamine 8300:Aldicarb 8234:Category 8139:Medicine 8008:Pakistan 7898:Allergan 7893:Alkermes 7795:Programs 7089:Shah S, 7020:23839755 6970:50016270 6941:(2002). 6931:16392744 6883:Archived 6858:April 4, 6852:Archived 6710:24425070 6667:Archived 6641:Archived 6608:Archived 6575:Archived 6554:16522573 6462:21990303 6419:Archived 6317:Archived 6288:15713943 6239:Archived 6143:Archived 6091:Archived 6060:Archived 6034:Archived 6008:Archived 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