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# Draft Guide on Atopic Dermatitis and Pediatric Studies
- URL: https://www.fdaweb.com/draft-guide-on-atopic-dermatitis-and-pediatric-studies/
- Published: 2018-04-06T12:00:00.000Z
- Updated: 2026-09-14T23:57:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141163

FDA has released a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM603702.pdf?ref=fdaweb.com) on “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.” The document addresses relevant age groups to study and how early in a drug’s development that pediatric patients should be included for such drug products. The recommendations are based on input the agency received from a 2015 Dermatologic and Ophthalmic Drug Advisory Committee meeting and a review of medical literature and relevant statutes and regulations. At the committee meeting, panel members recommended that pediatric studies generally should be initiated earlier during development.