FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Says Start With Kids in Pediatric Drug Trials for Atopic Dermatitis

Oct. 11, 2018

Sponsors of atopic dermatitis drugs for children don’t have to wait to test a drug’s safety or efficacy on adults before beginning pediatric trials, the FDA says in a new final guidance.

The policy reverses longstanding FDA recommendations that any drug trying to treat a disease by affecting the entire body start with adult trials. Atopic dermatitis is the dry, itchy rash caused by eczema that affects nearly 18 million Americans, most of them children. It often clusters with asthma and hay fever.

The agency says its U-turn was prompted by recommendations from a 2015 meeting of its Dermatologic and Ophthalmic Drug Advisory Committee.

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