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# GDUFA Research Supports Generic Drug Development
- URL: https://www.fdaweb.com/gdufa-research-supports-generic-drug-development/
- Published: 2022-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:58:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152648

The FY 2021 *GDUFA Science and Research Outcomes Report* demonstrates that research outcomes have played an increasing role over four years in supporting the development of generic drug products. A chart in the [report](https://www.fda.gov/drugs/generic-drugs/gdufa-science-and-research-outcomes-fiscal-year-2021?utm%5Fmedium=email&utm%5Fsource=govdelivery) shows the number of:

- pre-ANDA meetings affected by research increased from 62 in FY 2018 to 113 in FY 2021;
- controlled correspondences affected by research increased from 113 in FY 2018 to 457 in FY 2021;
- product-specific guidances decreased from 86 to 40;
- publications, presentations, and posters relevant to the category dropped slightly from 244 to 233;
- workshops that communicate scientific advances and regulatory advice to the generic drug industry went from 8 to 14; and
- other items relevant to the category such as general guidances went from 2 to 5.

Similar metrics are presented for GDUFA research supporting the generation of evidence needed to support efficient review and timely approval of ANDAs and GDUFA research supporting the evaluation of generic drug equivalence.

FDA says the annual report is prepared as part of the enhanced accountability and reporting commitments in GDUFA 2.