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GUIDANCE DOCUMENT

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products August 2026

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2017-D-6530
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” This guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of new drug or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on September 22, 2023.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))

If unable to submit comments online, please mail written comments to:

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-2017-D-6530.

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