Post by CDER Small Business and Industry Assistance (SBIA)

FDA has issued a final guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs”. https://lnkd.in/dqAiZx8g   It outlines standardized procedures for requesting, preparing, scheduling, conducting, and documenting these meetings, helping to ensure they are efficient, timely, and well-managed.   Highlights:  ➡️ Meeting types: Explains the types of meetings that meeting requesters can have with FDA about OTC monograph drugs, with specific timelines and procedures for each.  ➡️ Joint meeting procedures: Describes the process for multiple meeting requesters to participate in a meeting.  ➡️ Confidentiality: Clarifies when information submitted to FDA in connection with meetings is confidential.