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Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance

Executive Summary

Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

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