FDA (CDER)
GUIDANCE FINAL
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
Published: 7/14/2026Detected: 7/13/2026
Summary preview
Establishes FDA’s expectations and process for conducting formal meetings with sponsors or requestors seeking advice on Over-the-Counter (OTC) monograph drug development, regulatory strategy, and submissions.
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