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GUIDANCE DOCUMENT

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry August 2024

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2023-D-0044
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Generic Drugs

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.”  This guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA, or an applicant that has submitted to FDA, an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act).  Specifically, this guidance provides information on requesting and conducting PSG meetings with FDA (i.e., pre-submission PSG teleconferences, post-submission PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).  This guidance provides procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter.  This guidance finalizes the draft guidance for industry of the same title issued on February 21, 2023.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-0044.

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