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Pediatric Studies Of Systemic Atopic Dermatitis Drugs Should Start Earlier, US FDA Says

Executive Summary

Sponsors generally should begin pediatric studies after obtaining initial evidence of efficacy and safety from early phase adult trials rather than waiting until initial approval in adults, agency says in a new draft guidance; move toward earlier timeline for pediatric research aligns with recommendations from a 2015 advisory committee, and patient and professional groups.

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Toxicity Testing For Topical Drugs, Sunscreens Included, On Tap In US FDA Workshop

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.

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