Nitrosamine impurities guidance updated with more information related to root causes of formation, mitigation and implementation of recommended AI limits and setting of specification for the recommended acceptable intake in drug products. Guidance has updated from February 2021 Revision 1 to September 2024 Revision 2 complete details provided below:
Category: Regulatory
FDA revised guidance for industry titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.”
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.”