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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 explains FDA's general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B...
FAQs on Emergency Use Authorizations (EUAs) for …
- https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic
- The FDA’s guidance, Emergency Use Authorization of Medical Products and Related Authorities - Guidance for Industry and Other Stakeholders includes …
FAQs: What happens to EUAs when a public health …
- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends
- Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for …
Emergency Use Authorization | FDA
- https://cacmap.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
- The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, …
Emergency Dispensing Orders and Emergency Use …
- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-dispensing-orders-and-emergency-use-instructions-eui
- The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, …
Emergency Use Authorization of Medical Products and …
- https://www.federalregister.gov/documents/2017/01/13/2017-00721/emergency-use-authorization-of-medical-products-and-related-authorities-guidance-for-industry-and
- Section 3088 of the 21st Century Cures Act, signed into law by the President on December 13, 2016, (Pub. L. 114-255) amends sections 564, 564A, and 564B of the FD&C Act to add new authorities to: (1) …
Employers can't require Covid-19 vaccination under an …
- https://www.statnews.com/2021/02/23/federal-law-prohibits-employers-and-others-from-requiring-vaccination-with-a-covid-19-vaccine-distributed-under-an-eua/
- The abbreviated timelines for the emergency use applications and authorizations means there is much the FDA does not know about these products even as it authorizes them for emergency...
Emergency Use Authorization of Medical Products and …
- https://www.federalregister.gov/documents/2016/04/04/2016-07478/emergency-use-authorization-of-medical-products-and-related-authorities-draft-guidance-for-industry
- The purpose of this draft guidance is to explain FDA's current thinking about policies on the authorization of the emergency use of certain medical products under …
FDA Guidance Emergency Use Authorization for …
- https://downloads.regulations.gov/FDA-2020-D-1137-0019/attachment_1.pdf
- As stated in the “Emergency Use Authorization of Medical Products and Related Authorities” January 2017 guidance (Ref. 3), FDA recommends that a request for an …
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