FDA releases proposed commitment letter detailing changes to GDUFA IV program

The U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV).

The letter follows several months of negotiations with industry groups and sets out the agency’s intended modifications to the program.

The proposed changes are designed to streamline generic drug approvals and adjust fee structures, with final details to be refined through further review and public comment.