FDA Emergency Use Authorization of Medical Products and Related Authorities and Other Stakeholders

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Emergency Use Authorization of Medical Products and Related Authorities and Other Stakeholders[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于US。

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Emergency Use Authorization of Medical Products 1

and Related Authorities Guidance for Industry and Other Stakeholders This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION 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 2

564B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended or added by the 3

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) . The provisions in PAHPRA, described in section II of this guidance, include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats such as pandemic influenza. PAHPRA clarifies and enhances FDA’s authority to support emergency preparedness and response and foster the 1

This guidance was prepared by the Office of Counterterrorism and Emerging Threats (OCET) in cooperation with the Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Drug Evaluation and Research (CDER). 2

21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b. Section 564 was first added to the FD&C Act by the Project BioShield Act of 2004 (Public Law 108-276). Hereafter in this document, statutory references (e.g., “section __”) are to the FD&C Act, except where otherwise indicated. 3

Public Law 113-5. Section 3088 of the 21st Century Cures Act, signed into law by the President on December 13, 2016, amends sections 564, 564A, and 564B of the FD&C Act to add new authorities to: (1) authorize emergency use of unapproved animal drugs, (2) make applicable other emergency use authorities (e.g., to issue emergency dispensing orders, waive compliance with current good manufacturing practices (CGMPs), make available Centers for Disease Control and Prevention (CDC) emergency use instructions, and extend expiration dates) to approved animal drugs, and (3) allow unapproved animal drugs to be held for emergency use. While much of what is described in this guidance will apply to these new authorities, this guidance does not by its terms reference them; FDA asks anyone interested in utilizing these authorities to contact FDA directly to discuss how to proceed. FDA plans to review these new authorities and address any new procedural issues raised as we develop more experience with these new authorities.

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