D1S02-Rosencrance-v1.3-FINAL.pdf

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1、Pharmaceutical Quality Ensuring Patients Remain Top PrioritySusan Rosencrance,PhDDeputy Director of ScienceOffice of Pharmaceutical QualityCenter for Drug Evaluation and Research(CDER)Generic Drug ForumApril 22,20261LL2Pharmaceutical quality assures the availability,safety,and efficacy of every dose

2、.Everyone deserves confidence in their next dose of medicine.3 Operational Excellence Maintained assessment performance across programs despite disruptions Regulatory Review Performance 90%on-time performance across ANDA submissions and amendments*90%on-time completion for GDUFA controlled correspon

3、dence*Organizational Strategies Expand capacity:career development&crossing training Leverage innovation:Knowledge-Aided Assessment and Structured Application(KASA)&AI tools Maintaining Excellence*https:/www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drugs-program-fiscal-year-2025-act

4、ivities-report*https:/www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-generic-drug-user-fee-amendments-performance-generic-drug-applications-and-supplements Introducing FDA PreCheckA Two-Phase ApproachFDAs StrategyComprehensive program to accelerate high-priority new manufa

5、cturing facilities in the U.S.Core FeatureProactive engagement before facilities become operationalTargetNew domestic manufacturing facilities for critical medicines and supply chain strengthening4Key PreCheck DatesKey PreCheck Dates9/30/25 Public meeting10/30/25 Written comments due 2/1/26 Program

6、launch3/1/26 Submission deadline4/1/26 FDA selects finalists7/1/26 Engagements begin5Nitrosamines:Collaborative Approach to Patient SafetyNitrosamines:Collaborative Approach to Patient SafetyOur Shared Commitment:Addressing nitrosamine impurities while ensuring continued patient access to needed med