FDA Ups Generics Oversight
A US government study reports progress – but also highlights shortfalls
Charlotte Barker |
There have been a number of high-profile recalls of generic drugs in the US recently and with 80 percent of prescriptions in the country made up of generic drugs, the public and policy-makers alike are concerned. Following a request from Congress (1), the Office of Inspector General (OIG) of the US Department of Health & Human Services aimed to find out whether FDA oversight of generics manufacturers – particularly of those outside the US – is increasing in line with 2012’s FDA Safety and Innovation Act (FDASIA).
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