Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

The subject guidance document was developed to assist drug and biological product application holders in making safety-related labeling changes as required by statute. Specifically, section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)), added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to require certain safety-related labeling changes based on information that becomes available after approval of the drug or biological product. While these requirements are codified in agency regulations (21 CFR part 314 – drugs; 21 CFR part 601 – biologics), the guidance provides background and procedural information regarding agency implementation.

The latest form for Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act expires 2022-07-31 and can be found here.

Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statement

Federal Enterprise Architecture: Health - Consumer Health and Safety