Drugs

FY 2026 GDUFA Science and Research Priorities

FDA has published the eight FY 2026 Generic Drug User Fee Act science and research priority areas. The list was developed after a 6/3-6/4 public workshop to gather input on the priorities, a notice says.

The agency says the eight priority areas “encompass scientific challenges that the generic industry and FDA’s generic drug program identify as being significant over the coming years, and they also represent opportunities for scientific advances to accelerate access to generic versions of complex products and make the development of generic drugs more efficient and globally harmonized.”

The notice lists these eight research areas and the priorities they cover:

develop methods for generics to address impurities such as nitrosamines (4 priorities);
enhance the efficiency of equivalence approaches for complex active ingredients (2);
enhance the efficiency of bioequivalence approaches for complex dosage forms and formulations (2);
enhance the efficiency of bioequivalence approaches for complex routes of delivery (3);
enhance the efficiency of equivalence approaches for complex drug/device combination products (3);
improve the efficiency of bioequivalence approaches for oral and parenteral generic products (3);
facilitate the utility of model-integrated evidence to support demonstration of bioequivalence (3); and
expand the use of artificial intelligence and machine learning tools (3).

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