Public Health Emergency Use Authorization List

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FAQs on Emergency Use Authorizations (EUAs) for Devices

(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 unapproved medical products, or

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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Authorization of Emergency Use of Certain Medical Devices …

(Just Now) 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/2024/01/25/2024-01426/authorization-of-emergency-use-of-certain-medical-devices-during-covid-19-availability

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FAQ: Emergency Use Authorizations (EUAs) and COVID-19 Vaccines

(2 days ago) WEBJohns Hopkins experts in global public health, infectious disease, and emergency preparedness have been at the forefront of the international response to …

https://coronavirus.jhu.edu/vaccines/blog/faq-emergency-use-authorizations-eu-as-and-covid-19-vaccines

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COVID-19 Vaccine EUA Recipient/Caregiver Fact Sheets CDC

(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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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 treatments, including convalescent plasma. …

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

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Emergency Use Authorization of Covid Vaccines — Safety and …

(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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Statement from NIH and BARDA on the FDA …

(2 days ago) WEBToday, 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 …

https://www.nih.gov/news-events/news-releases/statement-nih-barda-fda-emergency-use-authorization-moderna-covid-19-vaccine

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COVID-19 vaccines: Dive deep on emergency use authorization

(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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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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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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Emergency Use Authorizations of COVID-19–Related Medical …

(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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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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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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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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Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap

(9 days ago) WEBNews. Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap. FOR IMMEDIATE RELEASE February 9, 2023. Contact: HHS Press Office …

https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html

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Federal Register :: Authorization of Emergency Use of Certain …

(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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List of Telehealth Services CMS

(2 days ago) WEBList of services payable under the Medicare Physician Fee Schedule when furnished via telehealth.List of Telehealth Services for Calendar Year 2024 (ZIP) - …

https://www.cms.gov/medicare/coverage/telehealth/list-services

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ED-Initiated Buprenorphine for Patients With Opioid Use Disorder

(8 days ago) WEBOpioid use disorder (OUD) is a major public health problem affecting an estimated 2 million Americans. 1,2 Opioid overdose rates are also increasing, with an …

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2811640

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B.C. moves to ban drug use in public spaces, taking more steps to …

(1 days ago) WEBB.C. is taking action to make illicit drug use illegal in all public spaces, including inside hospitals, on transit and in parks. strengthening health care and …

https://news.gov.bc.ca/releases/2024PREM0021-000643

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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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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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CMS Finalizes a New Prior Authorization and Health Information …

(8 days ago) WEBThe Department of Health and Human Services will announce how the Health Insurance Portability and Accountability Act (HIPAA) will apply to these prior …

https://www.asha.org/news/2024/cms-finalizes-a-new-prior-authorization-and-health-information-exchange-rule/

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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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