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.
You may also be interested in...
The past three years have seen an increase in number of orphan drug labels containing appropriate pediatric information.
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.
FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.