重新审议请求：FDA 评估流程概述及最佳实践-Shin.pdf

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1、Request for Reconsideration:Process Overview and Best Practices for FDA EvaluationJoe Shin,PharmDLead Regulatory Health Project ManagerDivision of Project Management,Office of Regulatory OperationsOGD|CDER|U.S.FDASBIA:Generic Drugs Forum 2025 April 9-10,2025fda.gov/cdersbiafda.gov/cdersbia2Learning

2、Objectives Explain the purpose of the Request for Reconsideration(RfR)at the Division Level Under GDUFA Describe what is an appropriate matter for a Request for Reconsideration Provide an overview of the RfR process Identify best practices for getting an RfR“Accepted”for FDA Evaluationfda.gov/cdersb

3、iafda.gov/cdersbia3Poll Question#1How many of you have submitted a Request for Reconsideration?A.Yes,I have submitted an RfR beforeB.No,I have not but I plan to soonC.No,I have never submitted an RfRfda.gov/cdersbiafda.gov/cdersbia4What is the purpose of an RfR?A request created to ensure open and p

4、rompt consideration of an applicants concerns for certain actions that relate to an ANDA and have scientific significance.fda.gov/cdersbiafda.gov/cdersbia5What is an Appropriate Matter for a Request for Reconsideration?FDA Regulatory action that relates to an ANDA and has scientific significance:Com

5、plete response letter(CRL)Classification of a major amendment to an ANDA or PASClassification of the standard assessment status of an ANDA,ANDA amendment,PAS,or PAS amendmentRefuse-to-receive decisionTentative approval letterFDA determination that a supplement-changes being effected or a supplement-

6、changes being effected in 30 days is a prior approval supplement(PAS)Denial of a reclassification of a facility-based major CRL amendmentDenial of a pre-ANDA meetingAn applicant may pursue a request for reconsideration of an acknowledgement letter even though it is not considered to be a regulatory