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  1. www.fda.gov › regulatory-information › search-fda-guidance-documentsEmergency Use Authorization of Medical Products

    Sep 12, 2022 · EMERGENCY USE AUTHORIZATIONS. A. EUA DECLARATION JUSTIFYING EMERGENCY USE. 1. Determinations to Support an EUA Declaration 2. Termination of an EUA Declaration. B. EUA MEDICAL PRODUCTS....

  2. www.fda.gov › news-events › press-announcementsFDA Takes Key Action in Fight Against COVID-19 By Issuing ...

    Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe...

  3. www.yalemedicine.org › news › what-does-eua-meanEmergency Use Authorization Vs. Full FDA Approval: What’s the ...

    Mar 7, 2022 · Put simply, an emergency use authorization (EUA) is a tool the Food and Drug Administration (FDA) can use to expedite the availability of medical products, including drugs and vaccines, during a public health emergency.

  4. www.fda.gov › medical-devices › emergency-situations-medical-devicesEmergency Use Authorizations for Medical Devices | FDA

    Feb 26, 2024 · On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) Zika Immunoglobulin M...

  5. www.cdc.gov › vaccines › covid-19COVID-19 Vaccine EUA Recipient/Caregiver Fact Sheets | CDC

    Learn more. For each COVID-19 vaccine authorized under an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) requires that vaccine recipients or their caregivers are provided with certain vaccine-specific EUA information to help make an informed decision about vaccination.

  6. www.nih.gov › news-events › news-releasesStatement from NIH and BARDA on the FDA Emergency Use...

    Dec 18, 2020 · Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its COVID-19 vaccine, which was co-developed with scientists at the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID).

  7. www.fda.gov › emergency-use-authorization-vaccines-prevent-covid-19Emergency Use Authorization for Vaccines to Prevent COVID-19

    Mar 13, 2023 · Emergency Use Authorization for Vaccines to Prevent COVID-19. This guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that...

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