重新審議請求：FDA 評估流程概述及最佳實踐-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

7、action.fda.gov/cdersbiafda.gov/cdersbia6Challenge Question#1Which of the following are inappropriate matters for an RfR?A.Major classification of a CRL(major to minor)B.Standard assessment status of a CRL response amendment(standard to priority)C.Major acknowledgement letter of a Discipline Review L

8、etter(DRL)response amendment(major to minor)D.Advice communicated in a General Advice Letterfda.gov/cdersbiafda.gov/cdersbia7RfR Process Flow Submit an RfRNot Accepted LetterAccepted Letter(Acknowledgement)NoYesGrant RfRDeny RfRDoes RfR meet the guidance?Well focus our attention here where we have t

9、he biggest opportunity for improvementReview RfRfda.gov/cdersbiafda.gov/cdersbia8Submitting an RfR Identify and fully explain what you want FDA to reconsider Submit within 7 calendar days from the FDA action date Submit the RfR as a separate amendment to the ANDAfda.gov/cdersbiafda.gov/cdersbia9Subm

10、itting an RfR Follow the Content and Format section of the RfR Final Guidance with emphasis on the following:Form FDA 356h and Cover Letter Identification of the applicants submission as a“Request for Reconsideration”Cover Letter Brief statement of each matter to be resolved Statement identifying th

11、e office that issued the decision on the matter that is the subject of the request for reconsideration List of documents previously submitted pertinent to the RfR Statement that no new information has been submitted in the RfRfda.gov/cdersbiafda.gov/cdersbia10Reasons for Not Accepted RfRs RfR did no

12、t include information specified in the bulleted list in the“Content and Format”section of the RfR Guidance.The RfR was not submitted as a standalone,separate submission.RfR includes new information/new analysis that was not considered before FDA took the action related to your RfR.fda.gov/cdersbiafd

13、a.gov/cdersbia11Best Practices for FDA EvaluationClearly state what you are requesting for reconsideration in your submission and that the matter is appropriate.Major to minor classificationStandard to priority classificationEnsure that the RfR process is the appropriate pathReclassification of Faci

14、lity-Based Major CRL AmendmentProvide a brief,but comprehensive statement of each matter to be resolved.Address all components of the“Content and Format”section of the RfR GuidanceEnsure that there is no new information/new analysis in your RfRRefer to the Final Guidance for Industry:Requests for Re

15、consideration at the Division Level Under GDUFA(October 2024)fda.gov/cdersbiafda.gov/cdersbia12Challenge Question#2Which one of the following will NOT result in an RfR Not Accepted Letter?A.New information/new analysis B.Does contain the information specified in the bulleted list in the“Content and

16、Format”section C.Not submitted as a separate amendmentD.Advice given to applicants in meetings or teleconferencesfda.gov/cdersbiafda.gov/cdersbia13ResourcesFinal Guidance for Industry:Requests for Reconsideration at the Division Level Under GDUFA(October 2024)GDUFA III Commitment Letterfda.gov/cders

17、biafda.gov/cdersbia14Summary Follow the Content and Format section of the RfR Guidance Make sure the matter is appropriate for an RfR Refer to the RfR Final Guidance for assistance Addressing these areas of improvement will reduce administrative burden.Questions?Joe Shin,PharmDLead Regulatory Health Project ManagerDivision of Project Management,Office of Regulatory OperationsOGD|CDER|U.S.FDA