Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

Issue Date: August 13, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

This guidance provides recommendations to sponsors and applicants of Prescription Drug User Fee Act (PDUFA) products on formal meetings with FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, including principles of good meeting management, procedures for requesting and conducting meetings, meeting types and formats, and examples to help determine the appropriate meeting type.

Download the Guidance Document