The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders.

On September 22, 2023, the US Food and Drug Administration (FDA or the Agency) released a draft guidance titled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” (the Draft Guidance). The Draft Guidance includes two new types of formal meetings to which FDA committed during user fee reauthorization negotiations that led to the Prescription Drug User Fee Act (PDUFA) VII.