Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of new drug or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 This draft guidance replaces the guidance "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" issued on December 29, 2017.
Abstract as published in the Federal Register.
See the structure of SPEQ’s reviewed analysis
Explorer members can open three bounded, human-reviewed previews each month. Full relationships, analysis, and implementation implications remain protected.
Sign in free to preview →The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.