David Rosen on Emergency Use Authorization (EUA)

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Round Two - FDA Issues Emergency Use Authorization for Moderna’s COVID-19 Vaccine

What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more

12/22/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Moderna Inc. , Pharmaceutical Industry , Vaccinations

FDA Issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine

What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older....more

12/15/2020 / Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Infectious Diseases , Pfizer , Pharmaceutical Industry , Vaccinations

Historic FDA Advisory Committee Vote on Pfizer and BioNTech’s COVID -19 Vaccine

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention and 1 no vote that based upon the available scientific evidence, the benefits of the Pfizer and BioNTech’s COVID-19 vaccine...more

12/11/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Pfizer , Pharmaceutical Industry , Vaccinations

FDA Increases Scrutiny of COVID-19 Serology Tests: What Commercial Manufacturers Need to Know

On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more

5/7/2020 / Centers for Disease Control and Prevention (CDC) , CLIA , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Virus Testing , World Health Organization

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David Rosen