GDUFA III 完整回复函 (CRL) 后科学会议经验-Argawal.pdf

1、Arun Agrawal,Ph.D.Division of Bioequivalence I(DBI),Office of Bioequivalence(OB),Office of Generic Drugs(OGD)CDER|US FDAGeneric Drug Forum April 9-10,2025Disclaimer:This presentation reflects the views of the authorand should not be construed to represent FDAs views or policies.Experiences from Post

2、-Complete Response Letter(CRL)Scientific Meetings in GDUFA IIIfda.gov/cdersbiafda.gov/cdersbia2Learning Objectives An overview of post-Complete Response Letter Scientific Meeting Requests(post-CRSMRs)per the GDUFA III Commitment Letter Learn when and how to utilize post-CRSMR to support generic drug

3、 developmentfda.gov/cdersbiafda.gov/cdersbia3Outline2022 GDUFA III Commitment Letter(CL)Post-CRSMRs:Grant scenariosComplex generic productsAnalysis of post-CRSMRs submitted from 10/01/2022 to 12/31/2024Case studiesPost-CRSMRs:Common reasons for meeting request denialPost-CRSMRs:Expectations for the

4、meeting packagePost-CRSMRs:Summaryfda.gov/cdersbiafda.gov/cdersbia4CL:Options For Engaging FDA Prior to Responding to the CRL1.Post-CRL Clarification Meeting Request(Post-CRCMR)To seek clarification concerning deficiencies identified in a CRL 2.Submission of a Controlled Correspondence(CC)To seek re

5、gulatory and/or scientific advice after issuance of a CRL3.Post-CRL Scientific Meeting Request(Post-CRSMR)To request scientific advice on possible approaches to address deficiencies identified in a CRL related to establishing equivalence https:/www.fda.gov/media/153631/download fda.gov/cdersbiafda.g

6、ov/cdersbia5Post-CRSMRs:Grant ScenariosFDA will grant the post-CRSMR if the following criteria are met:Complex generic product or in FDAs judgment the request raises issues that are best addressed via post-CRSMR and cannot be adequately addressed through CC;and Relates to one or more of the followin