FDA GUIDANCE · FINALAugust 12, 2026

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Administrative / Procedural

Issue date

August 12, 2026

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