606:
288:– 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.
130:
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
87:
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
200:
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
126:
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
209:. 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
115:. 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
687:
138:
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.
155:
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,
51:
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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
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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
123:), 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.
385:
Webb, Jamie; Shah, Lesha D.; Lynch, Holly
Fernandez (September 1, 2020). "Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization".
425:
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).
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233:(CDC), on April 27, 2009, the FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the
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FDA Authorizes
Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans.
427:"Expanded Access Programs, compassionate drug Use, and Emergency Use Authorizations during the COVID-19 pandemic"
325:
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299:. The vaccine had received emergency authorization in the United Kingdom earlier in the month, but according to
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FDA-regulated product ... used to diagnose, treat, or prevent a disease or condition caused by" such an agent.
584:"Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab"
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officials, this was only for certain batches of the vaccine. In the U.S., the VRBPAC supported an EUA for
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295:'s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend EUA for the
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213:. Conditions determining the applicability of such declarations may be specified by federal statute.
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under certain circumstances. The agency issued these EUAs for the use of certain powerful
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551:"Emergency Use Authorization (EUA) of Remdesivir for Coronavirus Disease 2019 (COVID-19)"
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499:"Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices"
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688:"2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee"
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Vaccines and
Related Biological Products Advisory Committee - 12/10/2020 meeting
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151:(FDCA) of 1938 (Public Law 75-717) as added and subsequently amended by the
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256:, the Secretary of HHS declared the public health emergency for the novel
360:"Emergency Use Authorization of Medical Products and Related Authorities"
284:(revoked, although its license for established indications remains), and
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concluding reflections on the EUA program and its potential future uses.
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609:
This article incorporates text from this source, which is in the
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Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013
147:
In the United States, EUAs are authorized by
Section 564 of the
663:"U.K. Approves Pfizer coronavirus vaccine, a first in the West"
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from one of several agencies or of a "material threat" by the
526:"U.S. Approves Abbott Labs Coronavirus Test For Hospital Use"
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CDC test kits for COVID-19. In 2020, the FDA issued EUAs for
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chemical, biological, radiological and nuclear (CBRN) threats
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After initial authorizations for serious diseases such as
38:) in the United States is an authorization granted to the
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646:: CS1 maint: bot: original URL status unknown (
221:(Title 3 of the Code of Federal Regulations).
566:"FDA Authorizes Remdesivir Drug for COVID-19"
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293:Center for Biologics Evaluation and Research
564:Holland S, Mason J, Maler S (May 1, 2020).
231:Centers for Disease Control and Prevention
196:Applicability and the animal efficacy rule
176:of 2016 (H.R. 34, Public Law 114–255) and
505:. FDA U.S. Food & Drug Administration
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252:On February 4, 2020, in response to the
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331:Pan American Health Organization (PAHO)
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229:In response to requests from the U.S.
136:Secretary of Health and Human Services
62:, to allow the use of a drug prior to
661:Benjamin Mueller (December 2, 2020).
7:
44:Federal Food, Drug, and Cosmetic Act
143:History of legal authority for EUAs
46:as added to and amended by various
276:, Fresenius Propoven 2% emulsion (
183:Tooltip Public Law (United States)
163:Tooltip Public Law (United States)
149:Federal Food Drug and Cosmetic Act
25:
387:The American Journal of Bioethics
131:effective for the specified use.
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297:Pfizer–BioNTech COVID-19 vaccine
260:virus, which causes the disease
99:, EUAs were also authorized for
594:(Press release). April 16, 2021
364:US Food and Drug Administration
326:European Medicines Agency (EMA)
321:World Health Organization (WHO)
211:Health and Human Services (HHS)
77:Secretary of Homeland Security
1:
399:10.1080/15265161.2020.1795529
117:presidential executive orders
725:Food and Drug Administration
590:Food and Drug Administration
484:Food and Drug Administration
443:10.1016/j.drudis.2020.11.025
219:presidential executive order
42:(FDA) under sections of the
40:Food and Drug Administration
709:Emergency Use Authorization
215:Code of Federal Regulations
121:Code of Federal Regulations
103:principally in response to
32:Emergency Use Authorization
18:Emergency-use authorization
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192:of 2017 (no short title).
479:FDA News, April 27, 2009"
105:public health emergencies
66:. It does not constitute
54:(PAHPRA), as codified by
235:2009 swine flu pandemic
101:medical countermeasures
291:In December 2020, the
174:21st Century Cures Act
205:are loosely known as
153:Project BioShield Act
431:Drug Discovery Today
225:Use during pandemics
203:animal efficacy rule
694:. December 3, 2020.
274:convalescent plasma
50:, including by the
667:The New York Times
570:The New York Times
282:hydroxychloroquine
134:EUAs end once the
93:pandemic influenza
73:state of emergency
307:'s mRNA vaccine,
254:COVID-19 pandemic
97:emerging diseases
16:(Redirected from
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286:bamlanivimab
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167:113–5 (text)
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111:, including
109:bioterrorism
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672:December 2,
509:October 19,
393:(9): 4–17.
711:by the FDA
337:References
270:remdesivir
258:SARS-CoV-2
245:swine flu
598:April 16,
407:221324833
309:mRNA-1273
719:Category
535:April 7,
461:33253920
315:See also
278:propofol
262:COVID-19
107:such as
68:approval
64:approval
503:fda.gov
452:7694556
370:May 14,
305:Moderna
179:Pub. L.
172:), the
159:Pub. L.
530:Forbes
459:
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217:or an
185:
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592:(FDA)
588:U.S.
403:S2CID
190:(PDF)
170:(PDF)
674:2020
648:link
634:2020
600:2021
537:2020
511:2020
457:PMID
372:2020
247:test
95:and
692:FDA
447:PMC
439:doi
395:doi
280:),
83:Use
36:EUA
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