D1S18-Kotsybar-v1.2-FINAL.pdf

1、Overview of the FDA Product-Specific Guidance(PSG)ProgramJoseph Kotsybar,Pharm.D.Regulatory Health Project ManagerOffice of Research and Standards(ORS)|Office of Generic Drugs(OGD)|Center for Drug Evaluation&Research(CDER)Generic Drug Forum,April 22,20262Learning Objectiveswww.fda.govUnderstand the

2、FDAs Product-Specific Guidance(PSG)program and its role in supporting Abbreviated New Drug Applications(ANDAs)Learn about the PSG process,GDUFA III commitments,and reasons for a PSG revisionIdentify available PSG online resources,withdrawn PSGs,and forecasting to aid in generic drug development plan

3、ningUnderstand how to utilize PSG public requests,public comments,and GDUFA III PSG teleconferences(T-Cons)and PSG meetings to engage with the FDA3What is a Product-Specific Guidance(PSG)?Reflects FDAs current thinking and expectations on how to develop a generic drug product therapeutically equival

4、ent to a specific reference listed drug(RLD)Contains product-specific recommendations Identifying the methodology for developing generic drugs and generating evidence recommended to support ANDA approval Including key science and research output Unique to the generic drug development programwww.fda.

5、gov4BE:BioequivalenceCurrent BE approach for a productPSGsRegulations(21 CFR 320)General Guidances5PSG is an Integral Part of the FDAs ANDA ProgramGDUFA ResearchStandards&GuidancesReviewPre-ANDA and ANDA MeetingsControlled CorrespondencesProduct-Specific Guidances6Starting in 2007,FDA has published

6、PSGs to provide clear and direct recommendations to ANDA applicantsBackground on PSGsMore than 2400 published PSGs on the FDA PSG webpage as of April 2026 30%for complex productshttps:/www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-developmentMAPP 5240.10 Classifying Appro