FDA Ex-U.S. Trial Filings Will Need “Explicit” Good Clinical Practice Info
Executive Summary
FDA is moving toward requiring more "explicit" information on good clinical practice procedures for non-U.S. trials, Senior Advisor for Clinical Science David Lepay, MD/PhD, said at the Drug Information Association EuroMeeting in Prague March 13
You may also be interested in...
Sponsors Should Manage Adverse Event Reports To Reduce IRB Burden – Lilly
Sponsors should be responsible for oversight of adverse event safety data review to reduce institutional review board burden, Lilly Project Leader Vish Watkins says
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