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# Topics from GDUFA 3 Reauthorization Meeting
- URL: https://www.fdaweb.com/topics-from-gdufa-3-reauthorization-meeting/
- Published: 2021-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:45:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148603

A 12/17/20 meeting of FDA and industry representatives to negotiate the reauthorization of GDUFA covered these topics, according to a meeting [summary](https://www.fda.gov/media/145552/download?ref=fdaweb.com) distributed by the agency: 

- industry asked the agency to consider harmonizing some technical terminology related to the mid-cycle discipline review letters with a publicly-facing policy document;
- FDA described and provided data on the steady increase in post-marketing changes submitted through post-approval supplements and changes being effected supplements and said that additional resources may be needed if the supplement volume continues to increase;
- FDA shared similar information on the steady and continued annual increases in controlled correspondences, often covering complex generic drug products; and
- FDA opened an initial discussion of a possible proposal to resource more timely consideration of suitability petitions.