US FDA's Pediatric Experts, Not Review Division, Should Have Final Say On Pediatric Trials, Former Official Says

 
• By Brenda Sandburg

Former Associate Commissioner Janice Soreth says views of pediatric experts should take precedence over those of division directors regarding pediatric trials.

Tablets, pills and capsules, that shape the silhouette of a baby. - Vector
FDA's pediatric experts should take regulatory lead on drugs In their field, former agency official advises

A former US FDA official told agency leaders that one way to improve drug development programs is to follow the advice of its pediatric experts in evaluating trials in the pediatric space.

Janice Soreth, former associate commissioner for special medical programs, recommended that for pediatric conditions or diseases that primarily occur in...

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