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FDA Holds Final GDUFA III Meeting With Industry

September 24, 2021

The FDA and industry are in the final editing phase for a draft FDA commitment letter for reauthorization of the Generic Drug User Fee Act (GDUFA) having wrapped up a series of negotiation meetings held their last meeting on Aug. 26.

In that meeting, the agency said it would make additional edits to the letter “as discussed” and send a revised letter to industry for review, marking the end of negotiations.

The current user fee program, GDUFA II, is authorized through fiscal 2022 and the FDA has been developing its commitments to industry for GDUFA III, which will cover fiscal 2023 through 2027.

GDUFA III will need to be enacted by Congress in order to take effect at the start of fiscal year 2023, which begins on Oct. 1, 2022.

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