FDA’s Review of Foreign Studies Comes Under OIG’s Microscope

The HHS Office of Inspector General (OIG) will examine how the FDA reviews data from foreign clinical trials submitted to support new drug applications and biologic license applications, and the extent to which drugmakers use foreign trials to support such applications. FDA officials interviewed for an OIG report in 2007 estimated that 20 percent to 30 percent of data used in NDAs come from foreign clinical trials, according to the OIG’s work plan for fiscal 2010, which was released last month.
Clinical Trials Advisor