D2S03-Gowravaram-v1.2-FINAL.pdf

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1、Madhusudhan GowravaramUS FDA/CDER/OPQ/OPQA III/Division XVIIGeneric Drug Forum(GDF),April 22-23,2026Silver Spring,MD 20903Regulatory Review Process for Type II Secondary DMFs2www.fda.govPurposeThis presentation will discuss the risk-based regulatory review process for the acceptance of Type II secon

2、dary DMFs for the adequacy of Type II primary DMFs supporting Abbreviated New Drug Applications(ANDAs)and some regulatory aspects of secondary DMFs.3www.fda.govObjectiveMany Type II drug master files(DMFs)refer to a secondary Type II DMF in support of their submissionsWhat are secondary DMFs and how

3、 do they impact the review of primary DMFsThe scope and role of a secondary DMF(starting material,intermediate,or an API)is a significant factor in evaluating their acceptance for a primary DMF Several case studies will be presented with different scopes and roles of secondary DMFs and the risk-base

4、d review approach in their evaluation Regulatory aspects of secondary DMFs will be discussed.4www.fda.govWhat are secondary DMFs and how do they impact the review of primary DMFs Secondary DMFs are DMFs referenced by a primary DMF for the process of its final drug substance synthesis A secondary DMF

5、 could be for a starting material,intermediate,or API There could be more than one secondary DMF associated with a primary DMF When there is a secondary DMF(s)associated with a primary DMF,the manufacturing process of the primary DMF drug substance is evaluated based on the information presented in

6、all the DMFs(primary and secondary)including facilities5www.fda.govWhat are secondary DMFs and how do they impact the review of primary DMFs Assessment of control of process impurities in the primary DMF drug substance is based on the overall control strategy of impurities presented in both primary