FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: REAUTHORIZATION OF THE GENERIC DRUG USER FEE AMENDMENTS; PUBLIC MEETING; REQUEST FOR COMMENTS

WASHINGTON, Aug. 11 -- Food and Drug Administration has issued a notice called: Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments.

The notice was published in the Federal Register on Aug. 11 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. GDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect fees to support human generic drug activities. The current legislative autho...