ICH Guidance To Clarify Submission Of Integrated Safety, Efficacy Summaries
Executive Summary
FDA plans to clarify in a guidance what companies should include in integrated summaries of safety and efficacy in common technical document submissions
You may also be interested in...
Artesunate Anti-Malarial Outcomes Confirmatory Trial Advised By Cmte.
The World Health Organization should conduct a trial of artesunate rectal capsules looking at 28-day clinical outcomes to confirm efficacy of the antimalarial product, FDA's Anti-Infective Drugs Advisory Committee said July 10
FDA Will Accept Common Technical Document Instead Of NDA In July 2001
FDA will begin accepting drug applications in the Common Technical Document format presented as early as July 2001.
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