FDA Issues Draft Guidance About Formal Meetings for OTC Monograph Drugs
Yesterday, the U.S. Food and Drug Administration issued a draft guidance for industry titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires FDA to issue guidance on formal meetings between the agency and sponsors or requestors of over-the-counter (OTC) monograph drugs (referred to as “meeting requesters”). This guidance specifies the procedures and principles for formal meetings between FDA and meeting requesters. As also required by the FD&C Act, it establishes procedures for meeting requesters to meet with FDA to obtain FDA’s advice on the studies and other information necessary to support submissions under section 505G of the FD&C Act, other matters relevant to the regulation of nonprescription drugs, and the development of new OTC monograph drugs. Finally, as required by the FD&C Act, the guidance also establishes procedures to facilitate efficient participation in joint meetings by multiple meeting requesters and/or organizations nominated by them to represent their interests.
Because these meetings can often represent critical points in the regulatory and development process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings. Therefore, the guidance also discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.
FDA has committed to specific performance goals in the context of the OTC monograph drug user fee program (OMUFA) that include management goals for formal meetings that occur between FDA and meeting requesters. These and other performance goals agreed to by FDA and industry are described in the “Over-the-Counter Monograph User Fee Program Performance Goals and Procedures,” commonly referred to as the OMUFA commitment letter (the updated goal dates, accounting for the enactment date of OTC monograph reform, can be accessed at https://www.fda.gov/media/146283/download).
Comments regarding this draft guidance should be submitted following the information in the notice of availability that will be posted in the Federal Register shortly. More information regarding OTC Monograph Reform is available on FDA’s OTC Monograph Reform webpage.
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