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# PDUFA Formal Meetings Guidance
- URL: https://www.fdaweb.com/pdufa-formal-meetings-guidance/
- Published: 2023-09-22T12:00:00.000Z
- Updated: 2026-09-14T18:57:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155398

*Federal Register* notice: FDA is making available a draft guidance entitled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” The document outlines the recommendations on formal meetings between the agency and sponsors about drug development and the review of new drug or biological drug products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-09-22/pdf/2023-20592.pdf?ref=fdaweb.com).