Home » Complex Products, Reviews Top Out FDA GDUFA Research Plans
Complex Products, Reviews Top Out FDA GDUFA Research Plans
The FDA has put equivalency of complex products and postmarket reviews at the top of its fiscal 2014 GDUFA research agenda. The agency’s Office of Generic Drugs is spending more time on review and policy development for complex products as branded drug-device combos, implants and transdermal systems take on new technology.
Washington Drug Letter
Washington Drug Letter
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