FDA 产品特定指南 (PSG) 计划概述-Kotsybar.pdf

1、Overview of the FDA Product-Specific Guidance(PSG)ProgramJoseph Kotsybar,Pharm.D.Regulatory Health Project Manager|Office of Research and Standards(ORS)|Office of Generic Drugs(OGD)|Center for Drug Evaluation&Research(CDER)|FDAGeneric Drug Forum-April 9th,2025fda.gov/cdersbiafda.gov/cdersbia2Underst

2、and the 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 adoption of ICH M13A Identify available PSG online resources and forecasting to aid in drug development planningUnderstand how t

3、o utilize PSG public requests,public comments,and GDUFA III PSG teleconferences(T-Cons)and PSG meetings to engage with the FDALearning Objectivesfda.gov/cdersbiafda.gov/cdersbia3 Reflects FDAs current thinking and expectations on how to develop a generic drug product therapeutically equivalent to a

4、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 programWhat is a Product

5、-Specific Guidance(PSG)?fda.gov/cdersbiafda.gov/cdersbia4Current BE approach for a productPSGsRegulations(21 CFR 320)General GuidancesNEW in 2024!M13A guidance supporting IR Solid Oral Dosage Forms BE:BioequivalenceIR:Immediate-Release fda.gov/cdersbiafda.gov/cdersbia5PSG is an Integral Part of the

6、FDAs ANDA ProgramGDUFA ResearchStandards&GuidancesReviewPre-ANDA and ANDA MeetingsControlled CorrespondencesProduct-Specific Guidancesfda.gov/cdersbiafda.gov/cdersbia6Starting in 2007,FDA has published PSGs to provide clear and direct recommendations to ANDA applicantsBackground on PSGsAs of 3/1/202