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Emergency Use Authorization of Medical Products
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities
- This guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces the following two guidance documents, Emergency Use ...
Emergency Use Authorization | FDA
- https://cacmap.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
- Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is …
Guidance Emergency Use Authorization of Medical …
- https://www.emergogroup.com/sites/default/files/file/usa-fda-emergency_use_authorization_of_medical_products.pdf
- Guidance Emergency Use Authorization of Medical Products For single copies of this guidance, please contact: Office of Counterterrorism Policy and Planning (HF-29) Office …
Emergency Use Authorization of Medical …
- https://www.federalregister.gov/documents/2017/01/13/2017-00721/emergency-use-authorization-of-medical-products-and-related-authorities-guidance-for-industry-and
- The guidance represents the current thinking of FDA on emergency use authorization of medical …
FDA Guidance Emergency Use Authorization for …
- https://downloads.regulations.gov/FDA-2020-D-1137-0019/attachment_1.pdf
- Products” (Ref. 2), and the guidance for industry and other stakeholders entitled “Emergency Use Authorization of Medical Products and Related Authorities” (Ref. 3). …
Emergency Use Authorization of Medical Products
- https://www.reginfo.gov/public/do/DownloadDocument?objectID=37090101
- GUIDANCE Emergency Use Authorization of Medical Products For single copies of this guidance, please contact: OfJice of Counterterrorism Policy and Planning (HF-29) OfJice …
Guidance; Emergency Use Authorization of Medical …
- https://www.federalregister.gov/documents/2007/07/26/07-3661/guidance-emergency-use-authorization-of-medical-products-availability
- FDA is announcing the availability of a guidance for industry, government agencies, and FDA staff entitled “Emergency Use Authorization of Medical Products.”. …
Fact Sheet: COVID-19 Public Health Emergency …
- https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html
- The ending of the COVID-19 PHE will not affect the FDA’s ability to authorize various products, including tests, treatments, or vaccines for emergency use. Existing …
Whether Section 564 of the Food, Drug, and …
- https://www.justice.gov/olc/file/1415446/download
- Vaccine Subject to an Emergency Use Authorization . Section 564(e)(1)(A)(ii)(III) Food, Drug, and Cosmetic Actof the concerns only the ... Emergency …
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