GDUFA 2019 Science and Research Report

CDER has published the FY 2019 GDUFA Science and Research Report detailing “significant accomplishments in developing the scientific basis supporting new and revised guidances for industry and in refining methods for the scientific evaluation of equivalence for generic drug products.” In FY 2019, the report says, FDA awarded 14 new research contracts and three grants for innovative research projects on generic drugs. It also used its laboratories and in silico (computer) resources to conduct more than 50 GDUFA Science and Research projects on complex active ingredients, formulations, or dosage forms; complex routes of delivery; complex drug-device combination products; and tools and methodologies for bioequivalence and substitutability evaluation.

The report provides detailed results for 13 areas of focus including research activities and comprehensive lists of grants and contracts that the Science and Research Program awarded in FY 2019.