Pediatric Studies: Industry Seeks Narrower, More Timely Requests From US FDA
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.
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EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.
US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
The past three years have seen an increase in number of orphan drug labels containing appropriate pediatric information.