Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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 This guidance finalizes the draft guidance of the same title issued on February 7, 2022.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).
Abstract as published in the Federal Register.
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