D1S13-Rothschild+Fine-v1.2-FINAL.pdf

1、Suitability PetitionsGeneric Drugs Forum Generic Drugs Forum April 22,2026April 22,2026Karen Rothschild,JDRegulatory CounselOffice of Generic Drugs(OGD)Office of Generic Drug Policy(OGDP)Division of Legal and Regulatory Support(DLRS)CDER|US FDAAndrew Fine,PharmD,BCPSCommander,USPHSAssociate Director

2、 for Regulatory AffairsOffice of Generic Drugs(OGD)Office of Safety and Clinical Evaluation(OSCE)CDER|US FDA2Learning Objectives Understand the use and purpose of a Suitability Petition Know the proper format and content of a suitability petition and learn how to submit List the reasons for denial o

3、f a suitability petition Provide progress update on GDUFA III Suitability Petitions Understand Suitability Petition assessment approach and Case Studies3What is a Suitability Petition?A request to submit an abbreviated new drug application(ANDA)that is different from the reference listed drug(RLD)in

4、 one or more of the following:Strength Route of administrationDosage formChange in one active ingredient in a fixed-combination drug product(i.e.,a drug product with multiple active ingredients)4Submitting a Suitability PetitionSuitability petitions are a type of citizen petition.Follow the format a

5、s outlined in 21 CFR 10.30Suitability petitions are submitted to Dockets Management Staff(DMS).Submissions,supplemental material,and amendments(i.e.,responses to information requests)related to a specific docket ID should be uploaded using FDAs Electronic Method for Specific Electronic Submissions v

6、ia docket ID FDA-2013-S-0610.All supplemental or supported related material(SRMs)and amendments must reference the previously assigned docket ID(ex.Subject:Amendment to FDA-2024-P-XXXX)for DMS to process it in compliance with the Code of Federal Regulations(CFR).For additional information,refer to I