Category: Regulatory

This updated guidance outlines how the assessment goals established by the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments made to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) submitted to the FDA. It also provides detailed information on the classification of amendments and how these classifications can impact… Continue reading FDA revised guidance for industry titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.”