Recently, Director of the Center for Drug Evaluation and Research at FDA, Janet Woodcock, addressed questions regarding the generic drug user fee act (GDUFA) and whether or not it will provide FDA the means to ensure quality. Woodcock stated that, while it’ll help fund globalization, currently it has limited impact. According to Nick Taylor’s article in In-Pharma, FDA has been attempting to oversee the global pharmaceutical supply chain. FDA is less interested in funding for increased resources, but more for powers to compliment the funds. They aim to bring to attention the problems with importing drugs in the US compared to other countries. Questions have risen regarding whether that would call for different domestic and overseas standards for manufacturers.
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