FDA’s latest annual report says 71% (911) of pending postmarketing study commitments promised by drug sponsors at the time of approval have never been started. This is almost unchanged from the year before (2006) when 899 (71%) were pending. Last year’s FDA Amendments Act gave the agency authority to order more postmarketing studies to address safety issues.
From the June 01, 2008 Issue of MM+M - Medical Marketing and Media
