In a report published Monday, the Government Accountability Office (GAO) raises questions about the US Food and Drug Administration’s (FDA) foreign inspections program for drugs and says the program ...
Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study quantifies a decade of oversight gaps. We first need rigorous, replicable ways to ...
The Food and Drug Administration responded to a health policy group requesting clear enforcement of alternative funding programs, or AFPs. The agency reiterated its regulation against the foreign ...