常见的生物等效性信息请求：促进审查流程的技巧-Lu.pdf

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1、Common Bioequivalence Information Requests:Tips for Facilitating the Review ProcessFang Lu,Ph.D.Division of Bioequivalence I,Office of Bioequivalence,Office of Generic DrugsCDER|U.S.FDAGeneric Drug Forum 2025April 10,2025Disclaimer:This presentation reflects the views of the author and should not be

2、 construed to represent FDAs views or policies.fda.gov/cdersbia2Learning ObjectivesTo present deficiencies that may trigger information requests(IRs)To identify the actionable recommendations that could potentially avoid these deficiencies,which may reduce the number of assessment cycles to achieve

3、BE adequacyfda.gov/cdersbia3Outline Purpose An overview of issued IRs Types of observed deficiencies Tips for avoiding these pitfalls Summaryfda.gov/cdersbia4PurposeUnder the GDUFA III commitment letter1,FDA agreed to promote transparency and communication between FDA and ANDA applicants for improvi

4、ng predictability and effectiveness of the review processWe would like to share with common themes that we observed in IRs issued in GDUFA III,Year 1We hope that a description of these deficiencies along with tips on how to avoid them will facilitate approval of your proposed drug productfda.gov/cde

5、rsbia5CRL,DRL and IR2 Complete Response Letter(CRL),“will be issued after the complete assessment of a received ANDA by all appropriate disciplines.”Discipline Review Letter(DRL),“is a letter used to convey FDAs preliminary thoughts on possible deficiencies found by a discipline assessor and/or asse

6、ssment team”Information Request(IR),“is a letterto request further information or a clarification of the information already provided”fda.gov/cdersbia6Issuance and Use of an IR2 An IR is a request for further information or clarification that is needed or would be helpful to allow completion of the