FDA Seeking Help From Outside Advisors On Mandatory Phase IV Safety Trials
This article was originally published in RPM Report
Executive Summary
FDA plans soon to begin asking its outside drug review advisory committees for help designing mandatory postmarketing safety studies. The agency got the authority to mandate these studies as part ofhte FDA Amendments Act drug safety reforms in 2007. Now FDA is finding that it is hard to initiatie discussions of these studies and to specify the size and scope of the trials.