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 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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J&J'S vaccine pause should be lifted -CDC advisers Use of Johnson & Johnson's COVID-19 vaccine should be resumed in the United States, advisers to U.S. health regulators said on Friday, after weighing evidence of the shot's link to extremely rare but.. Credit: Reuters - Politics Duration: 01:50Published on April 24, 2021

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Biophore seeks EUA from DCGI for Aviptadil inhalation for Covid-19 treatment IndiaTimes - Published 1 week ago
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Ocugen to take BLA route for Covaxin in US based on FDA recommendation; seek emergency use nod for Canada Bharat 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 1 week ago

Bio E's Corbevax may be India’s cheapest vaccine at Rs 250 per dose Biological 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 2 weeks ago
Natco gets EUA for Baricitinib use for Covid-19 treatment IndiaTimes - Published on May 3, 2021
Dr Reddy's gets EUA for Sputnik V IndiaTimes - Published on April 13, 2021

Covid-19: India approves Russian vaccine Sputnik V for emergency use India on Monday granted Emergency Use Authorisation (EUA) to Russia's anti-covid vaccine Sputnik V, as the country fights the second wave of coronavirus. The EUA approval comes on the day India.. IndiaTimes - Published on April 12, 2021
Dr Reddy's initiates EUA process for Russian Covid-19 vaccine Sputnik V IndiaTimes - Published on February 19, 2021
Pfizer wants India to order Covid-19 vaccine before pursuing approval Pfizer Inc will pursue its request for India to approve its Covid-19 vaccine if the government commits to buying shots, the US drugmaker told Reuters on Monday, even as global supplies tighten. Pfizer.. IndiaTimes - Published on January 25, 2021
Covaxin led to tolerable safety outcomes & enhanced immune responses, says Lancet Even as a controversy rages over the safety of India’s first indigenous Covid-19 vaccine Covaxin after it was granted Emergency Use Authorisation (EUA) even as Phase III efficacy trials are underway,.. IndiaTimes - Published on January 22, 2021

All-India vaccine rollout set for next week: Govt The government will roll out the Covid-19 vaccine next week, with health secretary Rajesh Bhushan saying this was set to happen within 10 days of emergency use authorisation being granted. The Indian.. IndiaTimes - Published on January 5, 2021
Vaccine war: Bharat Biotech chief lashes out at Serum Bharat Biotech founder and chairman Dr Krishna Ella on Monday lashed out at detractors who criticised the speed at which emergency use authorisation (EUA) was given to Covaxin, the company’s Covid-19.. IndiaTimes - Published on January 4, 2021
Happy New Year: Expert panel clears Oxford vaccine for India India moved closer to the rollout of its vaccination plan against Covid-19 with the subject expert committee of the drug regulator on Friday recommending emergency-use authorisation (EUA) for Serum.. IndiaTimes - Published on January 1, 2021	Covid-19: Vaccine makers asked to submit more data The drug regulator has asked Bharat Biotech and Serum Institute of India (SII), which have sought emergency use authorisation (EUA) for their anti-Covid vaccines, to submit updated safety and.. IndiaTimes - Published on December 9, 2020