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 This guidance finalizes the draft guidance of the same title issued on February 7, 2022.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).
US Federal Register - FDA Guidance Notices · July 14, 2026
Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
FDA finalizes guidance on procedures and principles for formal meetings between the Agency and OTC monograph drug sponsors or requestors.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.