Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs

Issue Date: October 3, 2018
Issued by: Center for Biologics Evaluation and Research
Topic(s): Clinical – Medical, Pediatric Product Development
Status: Final

Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.” This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis (AD). This guidance finalizes the draft guidance of the same name issued on April 9, 2018.

Download the Guidance Document