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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs.

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All written comments should be identified with this document's docket number: FDA-2022-D-0080.