Granted by the Food and Drug Administration in the US
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval.[1] It does not constitute approval 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 state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.[1]
^ ab"Emergency Use Authorization of Medical Products and Related Authorities". US Food and Drug Administration. January 2017. Retrieved May 14, 2020.
and 19 Related for: Emergency Use Authorization information
An EmergencyUseAuthorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal...
medical use in the United Kingdom in November 2021. In December 2021, the US Food and Drug Administration (FDA) granted an emergencyuseauthorization (EUA)...
COVID‑19. The US Food and Drug Administration (FDA) issued an emergencyuseauthorization for pemivibart in March 2024. In the US, pemivibart is authorized...
PMC 7309195. PMID 32576276. Commissioner, Office of the (2024-03-04). "EmergencyUseAuthorization". FDA. "How Drugs are Reviewed in Canada". Government of Canada...
(FDA) has issued the first emergencyuseauthorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These...
the time of the divestiture. In March 2020, Hologic received emergencyuseauthorization from the FDA for a test for SARS-CoV-2 to help mitigate the COVID-19...
hospitalization or death. In November 2020, the FDA issued an emergencyuseauthorization (EUA) for the combination of baricitinib with remdesivir, for...
distribution," noting that this depended on the government granting emergencyuseauthorization or product approval. California based laboratory, FOMAT, is part...
Although Sotrovimab was used world-wide against SARS-CoV-2, including in the United States under an FDA emergencyuseauthorization (EUA), the FDA canceled...
(November 2020). "Expanded Access Programs, compassionate drug use, and EmergencyUseAuthorizations during the COVID-19 pandemic". Drug Discovery Today. 26...
From April to June 2020, there was an emergencyuseauthorization for their use in the United States, and was used off label for potential treatment of...
emergencyauthorization for Pfizer–BioNTech's BNT162b2 COVID-19 vaccine for widespread use. On 11 December, the FDA gave emergencyuseauthorization for...
approval. In the United States, baricitinib is authorized under an emergencyuseauthorization (EUA) for the treatment of COVID-19 in hospitalized people aged...
or Badan Peng was Obat dan Makanan (Badan POM), has granted emergencyuseauthorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19...
Lilly as a treatment for COVID-19. The medication was granted an emergencyuseauthorization (EUA) by the US Food and Drug Administration (FDA) in November...
2021, the U.S. Food and Drug Administration (FDA) issued an emergencyuseauthorization (EUA) for Propofol‐Lipuro 1% to maintain sedation via continuous...
the U.S. Food and Drug Administration (FDA) issued an emergencyuseauthorization (EUA) for the use of peramivir based on safety data from phase I, phase...
casirivimab/imdevimab were given emergencyuseauthorizations by the US Food and Drug Administration to reduce the number of hospitalizations, emergency room visits, and...
first country to authorize the vaccine on an emergency basis on December 2, 2020. Emergencyuseauthorization in the United States was issued December 11...