FDA Drops Ultimate Guide to Scheduling Meetings with Itself
Published Date: 8/13/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of new drug or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on September 22, 2023.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Final FDA PDUFA Meeting Guidance
If you are a sponsor or applicant for a prescription drug or biologic under PDUFA, the FDA published final guidance on August 13, 2026 that outlines recommended procedures for formal meetings with FDA. The guidance describes meeting types, formats, timelines, and standardized steps for requesting, preparing, scheduling, conducting, and documenting meetings to help you obtain useful feedback for product development.
Added Scenarios, Clarifications, Formats
The final guidance adds additional scenarios for Type D meetings, clarifies Initial Targeted Engagement for Regulatory Advice for CDER and CBER product meetings, and includes information on meeting formats the FDA may grant. These changes finalize edits to the draft guidance originally issued on September 22, 2023 and are part of the guidance announced August 13, 2026.
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