Emergency Use Authorization
Granted by the Food and Drug Administration in the US
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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. 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.
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India's first mRNA Covid-19 vaccine to get Emergency Use Authorisation soonThe Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for India's first mRNA COVID-19 vaccine, sources have said. The Drugs controller general of..IndiaTimes - Published | |
Covid vaccine: Govt panel recommends EUA for Biological E's Corbevax for 5 to 11 yearsIndiaTimes - Published | |
Covid-19: Covovax gets DCGI’s EUA nod for 12-17-year-oldsIn a move that will further expand the basket of Covid vaccines approved for adolescents, the drug regulator has given emergency approval to Serum Institute of India’s Covovax for use in 12-17 year..IndiaTimes - Published | |
DCGI's EUA nod to Covovax for 12-17 years age groupIndia's drug regulator has granted restricted emergency use authorisation to Serum Institute of India's COVID-19 vaccine Covovax for the 12-17 years age group subject to certain conditions, official..IndiaTimes - Published | |
Biological E seeks EUA for Covid vaccine Corbevax for children in 5-12 age group: Official sourcesRecently, the subject expert committee recommended emergency use authorization (EUA) for Biological E's Covid-19 vaccine Corbevax for the age group of 12 to 18 years under certain conditions. The drugs..IndiaTimes - Published | |
Government panel recommends EUA for Covid vaccine Covovax for 12-17 age groupPrakash Kumar Singh, director-government and regulatory affairs at Serum Institute of India (SII), had submitted an application to the DCGI on February 21, seeking EUA for Covovax for the 12 to 17..IndiaTimes - Published | |
Covid: DCGI grants EUA to BE's Corbevax for use in kids aged 12-18 yearsVaccine maker Biological E Limited’s (BE), receptor binding domain (RBD) protein sub-unit Covid-19 vaccine Corbevax has bagged emergency use authorisation (EUA) from the Drugs Controller General of..IndiaTimes - Published | |
Bio E's Corbevax, SII's Covovax & antiviral drug Molnupiravir get EUA nodIn a significant boost for India’s fight against Covid-19, the Central Drugs Standard Control Organisation (CDSCO) has granted emergency use authorisation for two more Covid-19 vaccines – Corbevax..IndiaTimes - Published | |
Govt panel recommends EUA for Covid-19 vaccines Covovax, Corbevax, anti-Covid pill molnupiravirIndiaTimes - Published | |
Govt panel to review EUA application for generic Covid-19 pillThe subject expert committee (SEC) under India's drug regulator is expected to review the EUA applications of drug companies seeking approval for Merck’s antiviral pill, Molnupiravir, on Thursday.IndiaTimes - Published | |
Bharat Biotech's US partner Ocugen files EUA request with FDA for paediatric use of CovaxinIndiaTimes - Published | |
Expert panel recommends approving Covaxin for kidsThe final approval of EUA from the drug regulator and inclusion of the vaccine in the national Covid immunisation programme for the paediatric population will take a few more days as data submitted by..IndiaTimes - Published | |
Johnson & Johnson applies for Emergency Use Authorization of its single-dose Covid vaccine in IndiaJohnson & Johnson has applied for Emergency Use Authorization (EUA) of its single-dose Covid-19 vaccine in India, the global healthcare major said on Friday.IndiaTimes - Published Also reported by •DNA | Brazil's Anvisa provisionally suspends authorisation for exceptional import of 4 million Covaxin dosesAfter closing the emergency use authorisation (EUA) and Phase-3 clinical trials requests for Bharat Biotech’s Covaxin, Brazil’s health regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria)..IndiaTimes - Published |
After suspending Covaxin clinical trials, Brazil closes EUA requestAfter suspending the clinical trials of Covaxin following the termination of Bharat Biotech's MoU with its Brazilian partner Precisa Medicamentos, Brazil’s health regulator Anvisa (Agencia Nacional..IndiaTimes - Published | Zydus seeks nod for world’s first plasmid DNA Covid vaxHomegrown healthcare and pharmaceutical major Zydus Cadila has applied for emergency use authorisation (EUA) to the office of the Drug Controller General of India for ZyCoV-D, its plasmid DNA vaccine..IndiaTimes - Published |
Biophore seeks EUA from DCGI for Aviptadil inhalation for Covid-19 treatmentIndiaTimes - Published | Ocugen to seek full approval for Covaxin in US via BLA instead of EUABharat Biotech’s US partner Ocugen has dropped its plans of applying for an emergency use authorisation (EUA) for indigenously developed Covaxin and will be pursuing the biologics license application..IndiaTimes - Published |
Ocugen to take BLA route for Covaxin in US based on FDA recommendation; seek emergency use nod for CanadaBharat Biotech’s US partner Ocugen has dropped its plans of applying for an emergency use authorisation (EUA) for indigenously developed Covaxin and will be pursuing the biologics license application..IndiaTimes - Published | Bio E's Corbevax may be India’s cheapest vaccine at Rs 250 per doseBiological E’s recombinant protein Covid-19 vaccine, Corbevax, could well emerge as the most affordable of vaccines in the Indian market once it gets emergency use approval (EUA). Corbevax is slated..IndiaTimes - Published |
Natco gets EUA for Baricitinib use for Covid-19 treatmentIndiaTimes - Published | |
