← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEFebruary 12, 2024NOTICE — NO LEGAL EFFECT

Fiscal Year 2024 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments

What this record is not

Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEJun 21, 2024 · closed
APPLIES TO · SPEQ TAGDrug
Document type
Notice
Agency
Health and Human Services Department
Published
February 12, 2024
Comments close
June 21, 2024
Document number
2024-02841
Docket
FDA-2023-N-0119
ABSTRACT

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "FY 2024 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 stakeholders-- 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) 2025 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.

Abstract as published in the Federal Register.

READ THE FULL DOCUMENT

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.

View on federalregister.gov →

That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.

Create a free account