Pediatric Studies: Industry Seeks Narrower, More Timely Requests From US FDA

 
• By Brenda Sandburg

PhRMA asks FDA to consider expiration of pediatric exclusivity in requesting pediatric clinical trials; AbbVie describes eight-year effort to begin enrollment in Humira pediatric ulcerative colitis study.

Medical technology concept. Remote medicine. Electronic medical record.
Stakeholders tell FDA how it could help them overcome hurdles to conducting pediatric studies

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