2025仿制藥論壇（Generic Drugs Forum 2025）嘉賓演講PPT合集（共32套打包）

1、Closing RemarksCAPT Kendra StewartDeputy Director for OperationsOffice of Generic DrugsCDER|U.S.FDAGeneric Drugs Forum April 10,2025fda.gov/cdersbia2Key TakeawaysAt GDF 2025 we hope you were able to:。

2、Orange Book Drug Marketing StatusTruong Quach,PharmDLead PharmacistOffice of Generic Drugs Office of Generic Drug Policy Division of Orange Book Publication and Regulatory Assessment(DOBPRA)CDER|U.S.。

3、Building a Global Framework for Assessing Inactive Ingredients in Generic Drug ApplicationsPamela G.Dorsey,M.S.,Ph.D.Senior PharmacologistDivision of Bioequivalence III,Office of BioequivalenceCDER|U。

4、How to Leverage the Inactive Ingredient Database and Justify Excipient Safety in ANDAsQing Liu,Ph.D.Office of BioequivalenceJulia Yang,PhDPharmacologist,Division of Pharmacology/Toxicology Review(DPT。

5、GDUFA III Impact on DMF AssessmentJayani Perera,Ph.D.Senior Chemist,Division of Product Quality Assessment XIX,Office of Product Quality Assessment IIIOffice of Pharmaceutical Quality,CDER|US FDASBIA。

6、Request for Reconsideration:Process Overview and Best Practices for FDA EvaluationJoe Shin,PharmDLead Regulatory Health Project ManagerDivision of Project Management,Office of Regulatory OperationsOG。

7、Common Deficiencies in Drug Master Files(DMFs)David GreenSenior Pharmaceutical Quality Assessor Division of Product Quality Assessment XVII(DPQA XVII)|Office of Product Quality Assessment III(OPQA II。

8、Request for Reconsideration Under GDUFA III Overview and Experience from a Bioequivalence PerspectiveYi Zhang,Ph.D.Associate Division DirectorDivision of Bioequivalence III/Office of BioequivalenceOf。

9、Common Bioequivalence Information Requests:Tips for Facilitating the Review ProcessFang Lu,Ph.D.Division of Bioequivalence I,Office of Bioequivalence,Office of Generic DrugsCDER|U.S.FDAGeneric Drug F。

10、Minor Regulatory Errors with Major ConsequencesThu Suzanne Phan,PharmDPharmacist,Patent and Exclusivity TeamDivision of Legal and Regulatory Support(DLRS),Office of Generic Drug Policy(OGDP),Office o。

11、General Quality Considerations of Drug Products Labeled for Alternate Dosing AdministrationRavikanth Kona,PhDPharmaceutical ScientistOffice of Pharmaceutical QualityCenter for Drug Evaluation and Res。

12、Considerations When Submitting Proposed Excipient Levels in Inactive Ingredient(IIG)Controlled CorrespondencesZakia R.Williams-Greene,PhDSenior PharmacologistDivision of Bioequivalence I,Office of Ge。

13、Analysis of Common ANDA Major DeficienciesDarby Kozak,PhDDeputy Director Office of Generic Drugs|CDER|U.S.FDA10 April 20252025 Generic Drug ForumOutlineAnalysis of recent abbreviated new drug applica。

14、Bioequivalence Approaches for Nitrosamine Impacted ANDA Applications:Case StudiesParamjeet Kaur,Ph.D.Division of Bioequivalence II,Office of BioequivalenceOffice of Generic Drugs,CDER/FDA SBIA Generi。

15、Common Bioequivalence Deficiencies in Abbreviated New Drug Applications for Extended-Release Drug Products Juhyun Kim,Ph.D.Division of Bioequivalence III,Office of Bioequivalence,Office of Generic Dr。

16、Case Studies of Using Alternate Reference Standard in Bioequivalence StudiesXiaojian Jiang,Ph.D.Division of Bioequivalence II,Office of BioequivalenceOffice of Generic Drugs,CDER/FDA SBIA Generic Dru。

17、Working Together to Increase Access to Generic DrugsDarby Kozak,PhDDeputy Director Office of Generic Drugs|CDER|U.S.FDAGeneric Drugs ForumApril 9,2025Agenda State of the Generic Drug Program 2024 Abb。

18、1Advancing Pharmaceutical Quality Geoffrey Wu,Ph.D.DirectorOffice of Product Quality Assessment I Office of Pharmaceutical QualityCenter for Drug Evaluation and ResearchU.S.Food and Drug Administrati。

19、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 E。

20、Transparency Pilot for Enhanced CommunicationsScott Vehovic,MBA,R.Ph.Commander,US Public Health ServiceDivision of Project Management(DPM),Office of Generic Drugs(OGD)CDER|US FDAGeneric Drugs Forum A。

21、Common Discrepancies Observed on the Form 356h with theANDA SubmissionOnyeka Ihezie,PharmDRegulatory Business Process ManagerDivision of Regulatory and BusinessProcess Management I(DRBPMI)OPRO|OPQ|CD。

22、Best Practices for Generic Drug LabelingChurg“Stella”Chan,PharmD,BCPSDivision of Labeling Review(DLR),Office of Regulatory Operations(ORO),Office of Generic Drugs(OGD)CDER|US FDAGeneric Drugs Forum 2。

23、Impact of ICH M13A Implementation on Bioequivalence Assessment:Removal of Data due to Low ExposureDiana Vivian,Ph.D.Associate Division DirectorDivision of Bioequivalence II,OGD/OBCDER|US FDASBIA Gene。

24、ANDA Missed Goal DatesEdward SherwoodOffice of Regulatory OperationsOffice of Generic DrugsCenter for Drug Evaluation and ResearchApril 9,2025fda.gov/cdersbia2Learning Objectives Describe a missed go。

25、Pre-ANDA Meetings:Process and Best PracticesCaliope Sarago,MHSALead Regulatory Health Project ManagerOffice of Research and Standards/Office of Generic DrugsCDER|US FDAGeneric Drug Forum 2025 April 9。

26、Project Managing Drug Assessors Under Generic Drug User Fee Amendment(GDUFA)III RegulationsNuri Tawwab,PharmD,MPHLCDR,U.S.Public Health ServiceStakeholder Engagement TeamDivision of Prevention Commun。

27、Arun Agrawal,Ph.D.Division of Bioequivalence I(DBI),Office of Bioequivalence(OB),Office of Generic Drugs(OGD)CDER|US FDAGeneric Drug Forum April 9-10,2025Disclaimer:This presentation reflects the vie。

28、Navigating Challenges in Drug Manufacturing:Common Process Deficiencies and Pre-Approval Inspection ObservationsAndrew IdziorChemistOffice of Pharmaceutical Manufacturing AssessmentOPQ|CDER|US FDAGen。

29、Common Clinical Deficiencies in ANDAs Containing Comparative Clinical Endpoint StudiesYing Fan,Ph.D.Team Leader,Division of Clinical Review,Office of Safety and Clinical Evaluation,Office of Generic 。

30、Nitrosamine Related GuidanceReynolds Cantave,PharmDSr.Regulatory Business Process ManagerOffice of Quality Assurance,Office of Pharmaceutical QualityCDER|US FDAGeneric Drug Forum April 10,2025fda.gov。

31、OSIS Role in Conducting Inspections and Remote Regulatory Assessments(RRAs)of Abbreviated New Drug Application(ANDA)In Vitro Bioequivalent(BE)StudiesTahseen Mirza,PhD,MBA Associate Director for Regul。

32、Common Quality Major Deficiencies in ANDAsGeneric Drugs Forum(GDF)2025Fang Yuan,PhDSenior Pharmaceutical ScientistOffice of Product Quality Assessment I|OPQ|CDER|U.S.FDAApril 10,20252www.fda.govEvery。