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GUIDANCE DOCUMENT

Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs October 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-1175
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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 This guidance finalizes the draft guidance of the same name issued on April 9, 2018.

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