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USFDA Guidance: Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter (OTC) Monograph Drugs
Before submitting an Over-the-Counter (OTC) Monograph Order Request (OMOR) or advancing the development of an OTC monograph drug, early engagement with the U.S. Food and Drug Administration (FDA) can help sponsors clarify regulatory expectations, discuss scientific evidence, and address potential development challenges. Structured interactions with the Agency allow sponsors to obtain timely feedback, improve development planning, and support efficient regulatory decision-maki
Sharan Murugan
Jul 154 min read
USFDA Guidance: Format and Content for OTC Monograph Order Requests
Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph...
Sharan Murugan
Apr 12, 20231 min read