FDA releases FY23 GDUFA Science and Research Report

On Thursday, the US Food and Drug Administration’s (FDA0 Center for Drug Evaluation and Research published its  fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Report.

Each year, with public input, the FDA identifies generic drug science and research priorities that can help expand and accelerate patient access to generic drugs. The agency then advances research in those scientific areas through extensive collaborations among FDA scientists, as well as through multiple collaborations with research institutions around the world.

For example, GDUFA-funded research in the generic development of poly(lactide-co-glycolide) polymer products provided the scientific foundation for the approval of three generic products formulated with this polymer, including a generic to Vivitrol, a drug used for treating patients with alcohol use disorder and opioid dependence.