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Home » FDA’s Review of Foreign Studies Comes Under OIG’s Microscope
FDA’s Review of Foreign Studies Comes Under OIG’s Microscope
October 28, 2009
The HHS Office of Inspector General (OIG) will examine how the FDA reviews data from foreign clinical trials submitted to support new drug applications
(NDAs) and biologic license applications, as well as the extent to which drugmakers use foreign trials to support such applications.