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Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of new drug or biological drug products. This draft guidance replaces the guidance "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" issued on December 29, 2017.