Priorities & Projects

Each year, FDA consults with industry and the public to develop a list of regulatory science initiatives on generic drugs in accordance with the Generic Drug User Fee Amendments (GDUFA). These priorities are discussed and developed in public meetings and workshops and...

Updated list of approved active moieties

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic ActNOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric...