Bioequivalence requirements


More PSGs Added and Revised

Today in a prepublication Federal Register notice, (due to be published tomorrow), the FDA announced the addition of 29 new and 19 revised product specific guidance (PSG) documents.  The Agency acknowledges that, “as part of FDA’s commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference […]

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