FDA Recommends Early, Pre-Approval Trials in Pediatrics for Systemic Dermatitis Drugs

April 10, 2018

The FDA published a new draft guidance outlining how early sponsors should incorporate pediatric patients, and the relevant age groups, for systemic therapies for atopic dermatitis.

The FDA previously recommended that sponsors submit pre-approval data on the use of topical products, but it did not recommend pediatric studies of systemic drugs until after adult approval.

Now the draft guidance recommends sponsors initiate pediatric studies early in development, typically after obtaining initial evidence from early-phase adult studies. In addition, sponsors should discuss the specifics of their pediatric programs with the FDA as early as possible, as pediatric study plans are required by law to be submitted within 60 days after an end-of-Phase II meeting.

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