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# 8 New GDUFA Research Grants in FY 2023: Report
- URL: https://www.fdaweb.com/8-new-gdufa-research-grants-in-fy-2023-report/
- Published: 2024-05-23T12:00:00.000Z
- Updated: 2026-09-14T14:31:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157049

The FY 2023 GDUFA Science and Research Report says FDA awarded eight new grants and 12 new contracts during the fiscal year for innovative extramural research projects relevant to generic drugs. The agency also used its internal resources and expertise to conduct over 70 research projects designed to facilitate generic drug development and prepare the agency to assess information submitted in ANDAs, it [says](https://www.fda.gov/drugs/generic-drugs/fy-2023-gdufa-science-and-research-report?utm%5Fmedium=email&utm%5Fsource=govdelivery).

“The outcomes from GDUFA-funded research expand our understanding of drug products, including complex products, and often contribute to the development of advanced methods to characterize product quality and performance,” write Office of Generic Drugs director **Iilun Murphy** and Office of Pharmaceutical Quality director **Michael Kopcha**. “These methods enable efficient approaches for developing generic products and help FDA to assess the bioequivalence and quality of complex generic products.”

The report has chapters for each of the eight scientific areas that were identified in FY 2023 as GDUFA Science and Research Priority Initiatives. The chapters cover active research projects and outcomes for **(1)** impurities; **(2)** complex active pharmaceutical ingredients; **(3)** complex dosage forms and formulations; **(4)** complex routes of delivery; **(5)** drug-device combination products; **(6)** oral and parenteral products; **(7)** quantitative methods and models; and **(8)** data analytics and artificial intelligence. A ninth chapter reviews other generic product science and research.