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# FY 2023 GDUFA Research Priorities
- URL: https://www.fdaweb.com/fy-2023-gdufa-research-priorities/
- Published: 2022-10-26T12:00:00.000Z
- Updated: 2026-09-14T18:04:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153055

FDA has published the Fiscal Year 2023 GDUFA Science and Research Priority Initiatives that were developed in collaboration with industry and the public. The [document](https://www.fda.gov/drugs/generic-drugs/generic-drug-research-priorities-projects/?utm%5Fmedium=email&utm%5Fsource=govdelivery) lists eight areas encompassing scientific challenges that the generic drug industry and the FDA generic drug program identified as being significant over the next five years:

- develop methods for generics to address impurities such as nitrosamines;
- enhance the efficiency of bioequivalence approaches for complex active ingredients;
- enhance the efficiency of bioequivalence approaches for complex dosage forms and formulations;
- enhance the efficiency of bioequivalence approaches for complex routes of delivery;
- enhance the efficiency of bioequivalence approaches for complex drug-device combination products;
- improve the efficiency of bioequivalence approaches for oral and parenteral generic products;
- facilitate the utility of model-integrated evidence to support documentation of bioequivalence; and
- expand the use of artificial intelligence and machine learning tools.