FDA Issues Final Guidance About Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs

The U.S. Food and Drug Administration (FDA) 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.