GDUFA Science Priorities Will Assist Complex Drug Path Development

November 14, 2016 at 4:13 PM
Conducting research on how to establish equivalence of complex drug products is among the five fiscal 2017 scientific priorities of FDA's generic drug office. The focus is in line with the agency's recent announcement that it will use upcoming user fees to develop a new approval pathway for drugs with complex active ingredients, complex drug-device combination products and formulations. The office's other four scientific priorities are: Post-market evaluation of generic drug products. Bioequivalence pathways for locally-acting drugs. Therapeutic equivalence...


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