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United States FDA OTC Drugs

FDA Needs Industry Work Plan Before Granting Sunscreen Ingredient Rulemaking Deferrals

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Executive Summary

Industry must provide the agency with a draft plan by 3 Sept. describing the work it intends to conduct to support the generally recognized safety and effectiveness of eight chemical UV filters commonly used on today’s market. Without rulemaking deferrals, the active ingredients’ fate is uncertain as the 26 Nov. statutory deadline for a final OTC sunscreen drug monograph draws near.

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