FDA Drafts Guidance On Safety-Data Musts For GRASE Sunscreen Actives

Time and extent applicants seeking GRASE status for UV filters should provide FDA with the kind of clinical safety data used to support approval of chronic-use cutaneous drug products, and nonclinical testing should focus on potential long-term adverse effects, according to newly released draft guidance required from the agency under the Sunscreen Innovation Act. FDA is particularly interested in receiving comments about final formulation safety testing it anticipates requiring under specified monograph conditions.

FDA provides insight into its expectations for safety and effectiveness data supporting sunscreen ingredient GRASE determinations in a draft guidance released on deadline and 10 months after the agency's tentative rejection of eight related time and extent applications.

Prepared for publication in the Nov. 23 Federal Register, "Over-the-Counter Sunscreens: Safety and Effectiveness Data Guidance for Industry"...

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