595:
277:– all in response to the COVID-19 pandemic. On April 16, 2021, the FDA revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.
119:
The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that the FDA uses for product approvals, using a risk-benefit analysis based on "the totality of the scientific evidence available", it is "reasonable to believe" that the product may be
76:
EUAs have historically been infrequent. A review article by Rizk et al. provides a summary of the US experience in 2020 with pharmacological EUA approvals during the COVID-19 pandemic. It also provides a description of, and clinical rationale for, the EUA-approved drugs during the pandemic and
189:
EUAs may be applied to drugs, devices or biological product. EUAs may permit the emergency use of an unapproved drug, device or biologic product, or permit an unapproved use of an approved drug, device or biologic product. Furthermore, drugs, devices or biologic products may or may not have
115:
Consideration of a drug for an EUA requires a finding that it is "reasonable to believe" that the drug "may be effective" "to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a agent(s)" or to mitigate a disease or condition caused by an
198:. Under certain conditions, an EUA may authorize the emergency use in humans, of drugs, devices or biologic products approved under the animal efficacy rule. EUAs may also only be implemented during the period of a public health emergency as defined by a declaration of the Secretary of
104:. Subsequent legislative authorities expanded the class of drugs eligible for consideration, and the range of testing to which the drug or therapy has been subjected. The scope and applicability of EUAs is also affected by
676:
127:
determines that the precipitating emergency has ended (in consultation with the issuer of the appropriate state of emergency as necessary), or once the product or unapproved use is approved through normal channels.
144:
of 2004 (S. 15, Public Law 108–276) for funding of the development and procurement of medical countermeasures against CBRN threats, the
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307,
59:
of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared
487:
572:
40:
348:
190:
undergone human efficacy trials, due to risk, feasibility or ethical considerations. Drugs, devices or biologic products which have only been tested or approved under the
112:), which may affect the definition of the situations considered to be public health emergencies, and under which the authority of the FDA to issue EUAs may be exercised.
374:
Webb, Jamie; Shah, Lesha D.; Lynch, Holly
Fernandez (September 1, 2020). "Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization".
414:
Rizk, John G.; Forthal, Donald N.; Kalantar-Zadeh, Kamyar; Mehra, Mandeep R.; Lavie, Carl J.; Rizk, Youssef; Pfeiffer, JoAnn P.; Lewin, John C. (November 2020).
697:
199:
636:
124:
222:(CDC), on April 27, 2009, the FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the
514:
612:
253:, for deployment of the FDA EUA for certain medical devices involved in the diagnosis of COVID-19. In February 2020, The FDA issued an EUA for
281:
219:
93:
651:
713:
285:
32:
554:
137:
44:
319:
466:
FDA Authorizes
Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans.
416:"Expanded Access Programs, compassionate drug Use, and Emergency Use Authorizations during the COVID-19 pandemic"
288:. The vaccine had received emergency authorization in the United Kingdom earlier in the month, but according to
116:
FDA-regulated product ... used to diagnose, treat, or prevent a disease or condition caused by" such an agent.
65:
573:"Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab"
578:
472:
28:
292:
officials, this was only for certain batches of the vaccine. In the U.S., the VRBPAC supported an EUA for
203:
178:
109:
158:
284:'s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend EUA for the
166:
146:
314:
309:
202:. Conditions determining the applicability of such declarations may be specified by federal statute.
223:
175:
155:
630:
162:
89:
141:
235:
191:
226:
under certain circumstances. The agency issued these EUAs for the use of certain powerful
8:
540:"Emergency Use Authorization (EUA) of Remdesivir for Coronavirus Disease 2019 (COVID-19)"
463:
262:
440:
415:
391:
270:
81:
61:
488:"Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices"
48:
677:"2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee"
445:
395:
242:
435:
427:
383:
254:
231:
85:
387:
431:
207:
105:
36:
614:
Vaccines and
Related Biological Products Advisory Committee - 12/10/2020 meeting
289:
227:
707:
599:
52:
539:
140:(FDCA) of 1938 (Public Law 75-717) as added and subsequently amended by the
449:
274:
101:
97:
245:, the Secretary of HHS declared the public health emergency for the novel
349:"Emergency Use Authorization of Medical Products and Related Authorities"
273:(revoked, although its license for established indications remains), and
77:
concluding reflections on the EUA program and its potential future uses.
258:
246:
297:
266:
250:
598:
This article incorporates text from this source, which is in the
293:
41:
Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013
136:
In the United States, EUAs are authorized by
Section 564 of the
652:"U.K. Approves Pfizer coronavirus vaccine, a first in the West"
413:
64:
from one of several agencies or of a "material threat" by the
515:"U.S. Approves Abbott Labs Coronavirus Test For Hospital Use"
257:
CDC test kits for COVID-19. In 2020, the FDA issued EUAs for
184:
102:
chemical, biological, radiological and nuclear (CBRN) threats
80:
After initial authorizations for serious diseases such as
27:) in the United States is an authorization granted to the
131:
16:
167:
147:
617:. Archived from the original on December 10, 2020
552:
542:. U.S. Food and Drug Administration. May 1, 2020.
409:
407:
405:
343:
341:
339:
337:
335:
705:
649:
635:: CS1 maint: bot: original URL status unknown (
565:
402:
332:
210:(Title 3 of the Code of Federal Regulations).
555:"FDA Authorizes Remdesivir Drug for COVID-19"
373:
282:Center for Biologics Evaluation and Research
553:Holland S, Mason J, Maler S (May 1, 2020).
220:Centers for Disease Control and Prevention
185:Applicability and the animal efficacy rule
165:of 2016 (H.R. 34, Public Law 114–255) and
494:. FDA U.S. Food & Drug Administration
439:
512:
241:On February 4, 2020, in response to the
643:
320:Pan American Health Organization (PAHO)
213:
706:
218:In response to requests from the U.S.
125:Secretary of Health and Human Services
51:, to allow the use of a drug prior to
650:Benjamin Mueller (December 2, 2020).
33:Federal Food, Drug, and Cosmetic Act
132:History of legal authority for EUAs
35:as added to and amended by various
13:
265:, Fresenius Propoven 2% emulsion (
172:Tooltip Public Law (United States)
152:Tooltip Public Law (United States)
138:Federal Food Drug and Cosmetic Act
14:
725:
691:
376:The American Journal of Bioethics
120:effective for the specified use.
593:
286:Pfizer–BioNTech COVID-19 vaccine
249:virus, which causes the disease
88:, EUAs were also authorized for
669:
605:
583:(Press release). April 16, 2021
353:US Food and Drug Administration
315:European Medicines Agency (EMA)
310:World Health Organization (WHO)
200:Health and Human Services (HHS)
546:
532:
506:
480:
456:
367:
66:Secretary of Homeland Security
1:
388:10.1080/15265161.2020.1795529
325:
106:presidential executive orders
714:Food and Drug Administration
579:Food and Drug Administration
473:Food and Drug Administration
432:10.1016/j.drudis.2020.11.025
208:presidential executive order
31:(FDA) under sections of the
29:Food and Drug Administration
7:
698:Emergency Use Authorization
303:
204:Code of Federal Regulations
110:Code of Federal Regulations
92:principally in response to
21:Emergency Use Authorization
10:
730:
181:of 2017 (no short title).
468:FDA News, April 27, 2009"
94:public health emergencies
55:. It does not constitute
43:(PAHPRA), as codified by
224:2009 swine flu pandemic
90:medical countermeasures
280:In December 2020, the
163:21st Century Cures Act
71:
194:are loosely known as
142:Project BioShield Act
420:Drug Discovery Today
214:Use during pandemics
192:animal efficacy rule
683:. December 3, 2020.
263:convalescent plasma
39:, including by the
656:The New York Times
559:The New York Times
271:hydroxychloroquine
123:EUAs end once the
82:pandemic influenza
62:state of emergency
296:'s mRNA vaccine,
243:COVID-19 pandemic
86:emerging diseases
721:
685:
684:
673:
667:
666:
664:
662:
647:
641:
640:
634:
626:
624:
622:
609:
603:
597:
596:
592:
590:
588:
569:
563:
562:
550:
544:
543:
536:
530:
529:
527:
525:
510:
504:
503:
501:
499:
484:
478:
477:
460:
454:
453:
443:
411:
400:
399:
371:
365:
364:
362:
360:
345:
255:COVID-19 testing
232:quantitative PCR
173:
169:
153:
149:
108:(Title 3 of the
37:Acts of Congress
729:
728:
724:
723:
722:
720:
719:
718:
704:
703:
694:
689:
688:
675:
674:
670:
660:
658:
648:
644:
628:
627:
620:
618:
611:
610:
606:
594:
586:
584:
571:
570:
566:
551:
547:
538:
537:
533:
523:
521:
511:
507:
497:
495:
486:
485:
481:
462:
461:
457:
412:
403:
372:
368:
358:
356:
347:
346:
333:
328:
306:
228:antiviral drugs
216:
196:animal products
187:
171:
151:
134:
74:
49:§ 360bbb-3
17:
12:
11:
5:
727:
717:
716:
702:
701:
693:
692:External links
690:
687:
686:
668:
642:
604:
564:
545:
531:
513:Bruce Japsen.
505:
479:
455:
426:(2): 593–603.
401:
366:
355:. January 2017
330:
329:
327:
324:
323:
322:
317:
312:
305:
302:
290:European Union
230:, and for the
215:
212:
186:
183:
133:
130:
73:
70:
45:21 U.S.C.
15:
9:
6:
4:
3:
2:
726:
715:
712:
711:
709:
699:
696:
695:
682:
678:
672:
657:
653:
646:
638:
632:
631:cite AV media
616:
615:
608:
601:
600:public domain
582:
580:
574:
568:
560:
556:
549:
541:
535:
520:
516:
509:
493:
489:
483:
475:
474:
469:
467:
459:
451:
447:
442:
437:
433:
429:
425:
421:
417:
410:
408:
406:
397:
393:
389:
385:
381:
377:
370:
354:
350:
344:
342:
340:
338:
336:
331:
321:
318:
316:
313:
311:
308:
307:
301:
299:
295:
291:
287:
283:
278:
276:
272:
268:
264:
260:
256:
252:
248:
244:
239:
237:
233:
229:
225:
221:
211:
209:
205:
201:
197:
193:
182:
180:
177:
176:115–92 (text)
170:
164:
160:
157:
150:
143:
139:
129:
126:
121:
117:
113:
111:
107:
103:
99:
95:
91:
87:
83:
78:
69:
67:
63:
58:
54:
50:
46:
42:
38:
34:
30:
26:
22:
680:
671:
659:. Retrieved
655:
645:
621:December 10,
619:. Retrieved
613:
607:
585:. Retrieved
576:
567:
558:
548:
534:
522:. Retrieved
518:
508:
496:. Retrieved
491:
482:
471:
465:
458:
423:
419:
379:
375:
369:
357:. Retrieved
352:
279:
275:bamlanivimab
240:
217:
195:
188:
156:113–5 (text)
135:
122:
118:
114:
100:, including
98:bioterrorism
79:
75:
56:
24:
20:
18:
661:December 2,
498:October 19,
382:(9): 4–17.
700:by the FDA
326:References
259:remdesivir
247:SARS-CoV-2
234:swine flu
587:April 16,
396:221324833
298:mRNA-1273
708:Category
524:April 7,
450:33253920
304:See also
267:propofol
251:COVID-19
96:such as
57:approval
53:approval
492:fda.gov
441:7694556
359:May 14,
294:Moderna
168:Pub. L.
161:), the
148:Pub. L.
519:Forbes
448:
438:
394:
206:or an
174:
154:
47:
581:(FDA)
577:U.S.
392:S2CID
179:(PDF)
159:(PDF)
663:2020
637:link
623:2020
589:2021
526:2020
500:2020
446:PMID
361:2020
236:test
84:and
681:FDA
436:PMC
428:doi
384:doi
269:),
72:Use
25:EUA
19:An
710::
679:.
654:.
633:}}
629:{{
575:.
557:.
517:.
490:.
470:.
444:.
434:.
424:26
422:.
418:.
404:^
390:.
380:20
378:.
351:.
334:^
300:.
261:,
238:.
68:.
665:.
639:)
625:.
602:.
591:.
561:.
528:.
502:.
476:.
464:"
452:.
430::
398:.
386::
363:.
23:(
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.