By Jizhou Wang, Neeru Takiar

Published in: The AAPS Journal. vol. 24, Article N° 94 (2022)

Published on: August 30, 2022

Abstract We have summarized five high impact issues related to the stability studies for drug substances that are documented in the Type II drug master files (DMFs) supporting Abbreviated New Drug Applications (ANDAs). We intend to provide the scientific considerations for the regulatory policies which bear upon such high-impact issues. We have also provided our perspective to avoid such issues, to reduce the DMF review time, and subsequently to accelerate the approvals of the supporting ANDAs.

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