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# Industry GDUFA Reauthorization Counterproposals
- URL: https://www.fdaweb.com/industry-gdufa-reauthorization-counterproposals/
- Published: 2026-02-19T12:00:00.000Z
- Updated: 2026-09-14T13:34:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160693

At a 1/21 GDUFA 4 reauthorization negotiating session, industry representatives offered counterproposals and responses on several topics raised by FDA in previous sessions. Meeting [minutes](https://www.fda.gov/media/191133/download?attachment&ref=fdaweb.com) indicate that:

- Industry responded to FDA’s counter proposal on invoice timing and indicated FDA’s position would be acceptable, provided the agency ensures publicly available language highlights the statutory language that says firms will not be placed on the arrears list until 20 days after the 10/1 due date. FDA agreed to review where language could be placed on its GDUFA Web site.
- Industry presented a counter proposal to FDA’s proposal to update the prioritization Manual of Policies and Procedures to reflect an ongoing pilot that provides for ANDA prioritization when three conditions are met. Industry expressed interest in the agency proposal and suggested that prioritization occur if any two of the three criteria are met. Agency representatives said they would be interested in that approach for new ANDA submissions but not for supplements. No agreements were reached.
- Industry said it did not support FDA’s proposal to waive annual facility fees for the first three years for companies that break ground in the U.S. to manufacture one or more generic drugs or active pharmaceutical ingredients. Industry representatives said this would not be an effective incentive and could lead to higher fees for other companies to recover the lost revenue. FDA acknowledged the concerns and confirmed there would not be a counterproposal from industry.

Other topics covered were U.S. facility fee waiver and early facility inspections for U.S. facilities.