Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability

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 This guidance finalizes the draft guidance of the same title issued on September 22, 2023.