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

WASHINGTON, May 19 -- 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 May 19 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 on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins neg...