Public Health Emergency Use Authorization List

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Emergency Use Authorization FDA

(5 days ago) The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures(MCMs) … See more

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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COVID-19 Emergency Use Authorizations for Medical …

(4 days ago) WEBCOVID-19 Emergency Use Authorizations for Medical Devices. November 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of …

https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/covid-19-emergency-use-authorizations-medical-devices

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FAQs on Emergency Use Authorizations (EUAs) for …

(1 days ago) WEBThe FDA can use its Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the use of …

https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-related-covid-19

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COVID-19 Vaccine EUA Recipient/Caregiver Fact Sheets

(2 days ago) WEBCOVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheets for Recipients and Caregivers. Healthcare providers who administer the Moderna COVID-19 Vaccine (2023 …

https://www.cdc.gov/vaccines/covid-19/eua/index.html

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Federal Register :: Authorization of Emergency Use of …

(Just Now) WEBThe Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health …

https://www.federalregister.gov/documents/2023/01/23/2023-01180/authorization-of-emergency-use-of-certain-medical-devices-during-covid-19-availability

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Authorization of Emergency Use of a Medical Device …

(3 days ago) WEBThe Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that …

https://www.federalregister.gov/documents/2023/04/25/2023-08641/authorization-of-emergency-use-of-a-medical-device-during-covid-19-availability

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Emergency Use Authorization of Covid Vaccines — Safety …

(Just Now) WEBRecognizing the gravity of the current public health emergency and the importance of making a vaccine available as soon as possible, we believe that a median …

https://www.nejm.org/doi/full/10.1056/NEJMp2031373

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Emergency Use Authorizations of COVID-19–Related …

(3 days ago) WEBEmergency use authorization (EUA) enables the US Food and Drug Administration (FDA) to facilitate the availability of medical countermeasures when public health …

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2787205

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COVID-19 vaccines: Dive deep on emergency use …

(Just Now) WEBUnder this rubric, two candidates for FDA authorization as COVID-19 vaccines have been developed expeditiously during the public health emergency. But …

https://www.ama-assn.org/delivering-care/public-health/covid-19-vaccines-dive-deep-emergency-use-authorization

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Emergency Use Authorizations for Drugs and Non …

(5 days ago) WEBThe Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, …

https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products

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What Is Emergency Use Authorization? - Johns Hopkins

(9 days ago) WEBDuring the COVID-19 pandemic, the U.S. Food and Drug Administration has issued many emergency use authorizations—known as EUAs—for tests as well as …

https://publichealth.jhu.edu/2020/what-is-emergency-use-authorization

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Public Health Emergency Determinations to Support an …

(6 days ago) WEBSection 564. Public Health Emergency Determinations to Support an Emergency Use Authorization. The Pandemic and All Hazards Preparedness Reauthorization Act …

https://aspr.hhs.gov/legal/Section564/Pages/default.aspx

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COVID-19 Vaccines HHS.gov

(Just Now) WEBCOVID-19 Vaccines. October. October 20, 2021 FDA amended the emergency use authorizations (EUAs) to allow for a single booster dose the Moderna …

https://www.hhs.gov/coronavirus/covid-19-vaccines/index.html

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Authorization of Emergency Use of Certain Medical Devices …

(Just Now) WEBThe Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health …

https://www.federalregister.gov/documents/2022/07/22/2022-15699/authorization-of-emergency-use-of-certain-medical-devices-during-covid-19-availability

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Communicating Effectively About Emergency Use Authorization …

(3 days ago) WEBThe Emergency Use Authorization (EUA) mechanism is central to the US response to coronavirus disease 2019 (COVID-19). It allows the US Food and Drug Administration …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7893369/

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Emergency Use Authorizations (EUAs) Versus FDA Approval: …

(3 days ago) WEBEmergency use authorization (EUA) for an unapproved product review memorandum [Pfizer vaccine] December 11, 2020. Available at: Policy for coronavirus disease-2019 …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8101583/

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Emergency use listing - World Health Organization (WHO)

(8 days ago) WEBEmergency use listing. The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro …

https://www.who.int/teams/regulation-prequalification/eul/

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Emergency Use Authorization for Vaccines Explained FDA

(Just Now) WEBAn Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health …

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

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FDA releases transition plans for medical device enforcement

(4 days ago) WEBThe Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations …

https://www.aha.org/news/headline/2023-03-24-fda-releases-transition-plans-medical-device-enforcement-authorization-after-covid-19-public-health

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List of Public Health Emergency Declarations - ASPR

(9 days ago) WEBSeptember 12, 2023. Determination that a Public Health Emergency Exists As a Result of the Consequences of Hurricane Idalia in the State of Florida. Hurricane. Florida. August …

https://aspr.hhs.gov/legal/PHE/Pages/default.aspx

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COVID-19 Vaccines FDA - U.S. Food and Drug Administration

(7 days ago) WEBToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in …

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

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COVID-19 Emergency Use Authorization Declaration

(2 days ago) WEBOn March 15, 2023, the Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under …

https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration

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Emergency Use Authorization of Medical Products

(1 days ago) WEBAn authorized EUA will consist of (1) the signed letter of authorization and (2) any accompanying authorized materials (e.g., Fact Sheet for health care …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities

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