FDA Issues Final Guidance About Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs

The FDA has issued 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 the 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. The guidance discusses the procedures and principles for these formal meetings.

The final guidance reflects minor changes from the draft version that improve clarity, address comments to the docket for the draft guidance, and ensure consistency with the meeting formats in the guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” Additionally, the final guidance reflects commitments in OMUFA II and minor revisions consistent with section 505G of the FD&C Act.

• Read the Federal Register notice for additional information.
• For more information, including frequently asked questions about OTC monographs, visit OTC Monographs@FDA.

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