FDA, Industry Continue Work on a Draft GDUFA Commitment Letter

The FDA and industry representatives continue to work on a draft FDA commitment letter for reauthorization of the Generic Drug User Fee Act (GDUFA) following two meetings held in August to hammer out the details.

The current user fee program, GDUFA II, is authorized through fiscal 2022 and the FDA is developing its commitments to industry for GDUFA III, which will cover fiscal 2023 through 2027. In the Aug. 5 and Aug. 12 meetings, the negotiators also discussed other components of the GDUFA III package and pledged to meet again as needed.

GDUFA III will need to be enacted by Congress in order to go into effect at the start of FDA’s fiscal 2023 on Oct. 1, 2022.