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GUIDANCE DOCUMENT

Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs July 2026

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2022-D-0080
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of New Drugs

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs or organizations nominated by sponsors or requestors to represent their interests in a proceeding and discusses the procedures and principles for these formal meetings. This guidance finalizes the draft guidance of the same title issued on February 7, 2022. FDA is required to issue this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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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-2022-D-0080.

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