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U.S. Department of Health and Human Services


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Guidance & Regulation

Establishment & Maintenance of Records


FDA Actions on the Food Safety Modernization Act of 2011

In February 2012, FDA published an Interim Final Rule amending FDA’s regulation on the record availability requires in section 1.361 (21 CFR 1.361) as part of its implementation of the amendments to the Federal Food, Drug, and Cosmetic Act made by the FDA Food Safety Modernization Act.


FDA Actions on the Bioterroism Act of 2002