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GUIDANCE DOCUMENT

Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs February 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs.

Submit Comments

Submit Comments Online

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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