Pediatric Formula Best Effort Presumption Is Built Into Exclusivity - Botstein
Executive Summary
The expectation that drug manufacturers will use their best efforts to develop pediatric formulations is "built in" to FDA's pediatric exclusivity presumptions, former FDA Office of Drug Evaluation III Director Paula Botstein, MD, said June 3 at a Barnett Pediatric Drug Development meeting in Philadelphia, Pa.
You may also be interested in...
Pediatric Depression Claim Requires Two Efficacy Studies - Sample Request
A drug claim for depression in children and adolescents would require two full-scale efficacy studies, a June 29 FDA sample written request for antidepressant pediatric studies states.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011