Drugs

FY 2022 GDUFA Science, Research Outcomes

FDA has published the FY 2022 annual report on the extent to which GDUFA science and research-funded projects support the development of generic drug products, the generation of evidence needed to support efficient review and timely approval of ANDAs, and the evaluation of generic drug equivalence. The report contains tables with aggregate metrics of research outcomes for each of the three categories.

Examples of research supporting the development of generic drugs are the development of a new analytical method for improved product characterization or the development of an in vitro-in vivo correlation that informs formulation organization.

Research supporting the generation of evidence for ANDA review and approval could be the development of an analytical method demonstrating active pharmaceutical ingredient sameness or the development of a new bioequivalence study design.

Examples of research supporting the evaluation of generic drug equivalence are alternative methods to demonstrate equivalence.

FDA says the report is part of the enhanced accountability and reporting commitment in the GDUFA 2 amendments of 2017.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome