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Notice2023-01029

Mpox: Development of Drugs and Biological Products; Draft Guidance for Industry; Availability

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
January 20, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Mpox: Development of Drugs and Biological Products." FDA is issuing this guidance to support sponsors in their development of drugs and biological products for mpox.

Indexed from Federal Register on January 20, 2023.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.