OTC Monograph Stakeholders Seek Confidentiality Assurances Ahead Of OMOR Meetings With FDA
Executive Summary
Judging by January draft guidance from the US FDA, the agency may feel compelled to make public any information a party submits in the context of a meeting to discuss data needs for an OTC monograph change. And special sunscreen considerations included in the CARES Act, which overhauled the FDA's OTC drug review program, aren't mentioned in the guidance, trade groups say.
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