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FDA (CDER)
GUIDANCE FINAL
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Published: 8/12/2026Detected: 8/12/2026

Summary preview

Clarifies how FDA will conduct and manage formal meetings with sponsors/applicants for PDUFA-related products, including expectations for requests, agenda, and information submission to support timely Agency decisions.

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clinical
safety
labeling
quality
manufacturing
#formal meeting
#FDA-CDER
#PDUFA
#sponsor
#applicant

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