FDA meeting minutes are official records of the meetings documenting the meeting outcomes, agreements, disagreements, and action items. The FDA will issue the official finalized minutes to the sponsor within 30 days, after the meeting has been conducted. For more information on what will be included within the FDA meeting minutes, please refer to the FDA guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (guidance for industry).
Note: Even though the minutes issued by the FDA are generally considered final, the sponsor has the option of sending their meeting minutes to the FDA prior to the release of the final minutes. This additional step can provide a nuanced perspective on the sponsor’s position. However, please note that the minutes should be a report of the topic(s) discussed and not include any new information.