Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments

The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled "Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop." The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of interested parties--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.