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

 
• By Sue Sutter

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and safety from early phase adult trials rather than waiting until initial approval in adults, agency says in a new draft guidance; move toward earlier timeline for pediatric research aligns with recommendations from a 2015 advisory committee, and patient and professional groups.

Small kid taking a view of a plastic house.

The US FDA is moving up the timeline for pediatric studies of systemic treatments for atopic dermatitis.

Sponsors should begin pediatric studies "typically after obtaining initial evidence of efficacy and safety from early phase studies in adults"...

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