OTC Monograph Stakeholders Seek Confidentiality Assurances Ahead Of OMOR Meetings With FDA
Judging by January draft guidance from the US FDA, the agency may feel compelled to make public any information a party submits in the context of a meeting to discuss data needs for an OTC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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Stakeholders didn’t indicate extensive familiarity with OTC monograph user fees during online workshop. Biden administration’s FDA FY2023 budget request includes $5m increase to $30.36m in facility registration fees required from all firms manufacturing OTC monograph drugs available in US.
Recent draft guidance on scheduling and conducting meetings with FDA supported by OTC monograph user fees largely tracks with agency’s guidance for meetings supported by other user fee programs, such as PDUFA.
The House Appropriations Committee asks the US Food and Drug Administration to provide a report to Congress in two years on the resources it would need to develop a database for fragrance allergens used in cosmetics. The committee’s report accompanying FY2023 FDA funding legislation also touches on OTC sunscreen regulation, PFAS in cosmetics, skin-lightening ingredients, and more.