Generic Drugs Forum (GDF) 2026 April 22 - 23, 2026

Forum | Mixed

• Date: April 22 - 23, 2026
• Day1: Wed, Apr 22
• Day2: Thu, Apr 23

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Topics & Presentations	Speakers
Generic Drugs Forum (GDF) 2026: Day One – Keynote & Session 1
Office of Generic Drugs (OGD) Keynote Recording and Slides	Darby Kozak, PhD Deputy Director Office of Generic Drugs (OGD) | CDER
Office of Pharmaceutical Quality (OPQ) Keynote Recording and Slides	Susan Rosencrance, PhD Deputy Director for Science Office of Pharmaceutical Quality (OPQ) | CDER
Controlled Correspondences Recording and Slides	Marcia Fields, PharmD Lieutenant Commander United States Public Health Service (USPHS) Regulatory Officer Office of Regulatory Operations (ORO) OGD | CDER
Common Bioequivalence (BE) Study Design Deficiencies and How to Avoid Them Recording and Slides	Zhen Zhang, PhD Master Pharmacologist Division of Bioequivalence I (DB I) Office of Bioequivalence (OB) OGD | CDER
Proactive Strategies to Avoid Major Filing Deficiencies and Other Filing Stumbling Blocks Recording and Slides	Truong-Vinh “Vinh” Phung, PharmD Commander United States Public Health Service Regulatory Officer Division of Filing Review (DFR) ORO | OGD | CDER
An Update on CDER’s Quality Management Maturity (QMM) Program Recording and Slides	Eric Twum, PhD Regulatory Specialist Division of Quality Intelligence II (DQI II) Office of Quality Surveillance (OQS) OPQ | CDER
Questions & Panel Discussion 1 Recording	Marcia Fields, Zhen Zhang, Truong-Vinh Phung, Eric Twum and joined by: Julia Lee, PharmD Deputy Division Director DFR | ORO | OGD | CDER Christina Marshall, MS Project Manager ORO | OGD | CDER
Generic Drugs Forum (GDF) 2026: Day One – Session 2
Using FDA’s Inactive Ingredient Database (IID): Best Practices and Considerations Recording and Slides	Diana A Solana-Sodeinde, PharmD, MPH Commander United States Public Health Service Lead Program Coordinator for FDA’s Inactive Ingredient Database Immediate Office (IO) OB | OGD | CDER
Standardized Principles Used to Determine Maximum Daily Dose Recording and Slides	Melanie Mueller, PharmD, PhD Master Toxicologist Division of Pharmacology/Toxicology Review (DPTR) Office of Safety and Clinical Evaluation (OSCE) OGD | CDER
Complex Drug Products – Quality Considerations for Generic Oligonucleotides Recording and Slides	Likan Liang, PhD Supervisory Pharmaceutical Scientist Division of Product Quality Assessment X (DPQA X) Office of Product Quality Assessment II (OPQA II) OPQ | CDER
Questions & Discussion Panel 2 Recording	Diana A Solana-Sodeinde, Melanie Mueller and Likan Liang
Generic Drugs Forum (GDF) 2026: Day One – Session 3
FDA Commissioner Keynote Recording	Martin Makary, MD Commissioner U.S. Food and Drug Administration (FDA)
Suitability Petitions Recording and Slides	Karen Rothschild, JD Regulatory Counsel Division of Legal and Regulatory Support (DLRS) Office of Generic Drug Policy (OGDP) OGD | CDER Andrew Fine, PharmD, BCPS Commander United States Public Health Service Associate Director for Regulatory Affairs Office of Clinical Review OGD | CDER
Prioritizing Original and Supplemental ANDAs Recording and Slides Prioritization Requests Slides	Bayli Larson, PharmD Pharmacist DLRS | OGDP | OGD | CDER Andrew Kim, PharmD CommanderUnited States Public Health Service Supervisory Project Manager Division of Project Management (DPM) ORO | OGD | CDER
Addressing Patent and Exclusivity Requirements – Regulatory Reminders Recording and Slides	Heather Strandberg, PharmD Pharmacist Patent and Exclusivity Team (PET) DLRS | OGDP | OGD | CDER
Orange Book: How Drug Product Listings are Added, Updated, and Maintained Recording and Slides	Truong Quach, PharmD Team Lead Pharmacist Division of Orange Book Publication and Regulatory Assessment (DOBPRA) OGDP | OGD | CDER
Questions & Discussion Panel 3 Recording	Andrew Fine, Heather Strandberg, Truong Quach And joined by: Rosanne (Rosie) Pagaduan, PharmD Supervisory General Health Scientist DFR | ORO | OGD | CDER
Generic Drugs Forum (GDF) 2026: Day One – Session 4
Overview of the FDA Product-Specific Guidance (PSG) Program Recording and Slides	Joseph Kotsybar, PharmD Regulatory Health Project Manager Office of Research and Standards (ORS) OGD | CDER
Decoding PSGs for Complex Non-Oral Generics Recording and Slides	Yan Wang, PhD Deputy Director Division of Therapeutic Performance I (DTP I) ORS | OGD | CDER
Product-Specific Guidances (PSGs) in Action – Key Lessons and Common Questions in Oral Generic Drug Development Recording and Slides	Myong-Jin (MJ) Kim, PharmD Division Director Division of Therapeutic Performance II (DTP II) ORS | OGD | CDER
Drug-Device Combination Products: A Quality Perspective Recording and Slides	Sheela Rajesh, PhD Senior Pharmaceutical Quality Assessor OPQA II | OPQ | CDER
Questions, Panel Discussion 4 and Closing Recording	Joseph Kotsybar, Yan Wang, Myong-Jin (MJ) Kim, Sheela Rajesh and joined by: Dave Coppersmith, JD Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD | CDER

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Topics & Presentations	Speakers
Generic Drugs Forum (GDF) 2026: Day Two – Session 5
Factors that Can Facilitate Assessment of Type II Drug Master Files (DMFs) Recording and Slides	Erin Skoda, PhD  Supervisory Pharmaceutical Scientist  Office of Product Quality Assessment III (OPQA III) Office of Pharmaceutical Quality (OPQ) | CDER
Managing Your Letters of Authorization (LOAs) Recording and Slides	Deborah Johnson, PhD Supervisory Pharmaceutical Scientist OPQA III | OPQ | CDER
Regulatory Review Process for Type II Secondary DMFs Recording and Slides	Madhusudhan Gowravaram, PhD Acting Supervisory Pharmaceutical Scientist OPQA III | OPQ | CDER
Questions & Panel Discussion 5 Recording	Erin Skoda, Deborah Johnson and Madhusudhan Gowravaram
Generic Drugs Forum (GDF) 2026: Day Two – Session 6
Pre-Abbreviated New Drug Application (ANDA) Meetings for Complex Drug Products: Do’s and Don’ts from the Quality Perspective Recording and Slides	Sherry Bai, PhD Chemist Office of Product Quality Assessment I (OPQA I) OPQ | CDER
Common Microbiology Deficiencies for Ophthalmic Suspension Drug Products Recording and Slides	Arlene Chen, PhD Pharmaceutical Scientist Division of Pharmaceutical Manufacturing Assessment III (DPMA III) Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Generic Drugs (OGD) | CDER
Common Manufacturing Deficiencies for Complex Dosage Forms Recording and Slides	Amit Kokate, PhD Senior Biologist DPMA III | OPMA | OGD | CDER Vicky He, MS Senior Chemist DPMA III | OPMA | OGD | CDER
Data Integrity in ANDA Applications Recording and Slides	Ke Ren, PhD Deputy Division Director Division of Bioequivalence III (DB III) Office of Bioequivalence (OB) OGD | CDER
Questions & Discussion Panel 6 Recording	Sherry Bai, Arlene Chen, Amit Kokate, Vicky He and Ke Ren
Generic Drugs Forum (GDF) 2026: Day Two – Session 7
Best Practices for Safety Assessment of Nitrosamines in Generic Drugs Recording and Slides	Xin Fu, PhD, DABT Senior Pharmacologist Division of Pharmacology Toxicology Review (DPTR) Office of Safety and Clinical Evaluation (OSCE) OGD | CDER
Bioequivalence (BE) Recommendations for Bridging Pre- and Post-Mitigation Formulations of Nitrosamine-Impacted Drug Products: Case Studies Recording and Slides	Min Guo, PhD Pharmacokineticist Division of Bioequivalence I (DB I) OB | OGD | CDER Paramjeet Kaur, PhD Lead Pharmacokineticist Division of Bioequivalence II (DB II) OB | OGD | CDER
Nitrosamine Updates and Issues Observed Recording and Slides Perspectives on Nitrosamine Risk Reduction in Manufacturing Slides	Yuanling Liang, PhD Senior Chemist OPQA III | OPQ | CDER Diaa Shakleya, PhD Senior Research Scientist Office of Pharmaceutical Quality Research (OPQR) OPQ | CDER
A Risk-Based Approach to Extractables and Leachables Evaluations Recording and Slides Extractable/Leachable Safety Assessment in Generic Drug Products Slides	Jin Xu, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment IX (DPQA IX) Office of Product Quality Assessment II (OPQA II) OPQ | CDER Vincent Crowley, PhD Senior Pharmacologist DPTR | OSCE | OGD | CDER
Questions & Panel Discussion 7 Recording	Xin Fu, Min Guo, Paramjeet Kaur, Yuanling Liang, Diaa Shakleya, Jin Xu, Vincent Crowley and joined by: Andre Raw, PhD Associate Director for Science and Communication Office of Pharmaceutical Quality Assessment I (OPQA I) OPQ | CDER
Generic Drugs Forum (GDF) 2026: Day Two – Session 8
ICH M13A High-Risk vs. Low-Risk Case Studies – Bioequivalence (BE) Implications Recording and Slides	Suman Dandamudi, PhD Lead Pharmacologist DB III | OB | OGD | CDER
Bioanalysis of Endogenous Drugs Using Surrogate Matrix Approach in Abbreviated New Drug Applications: ICH M10 Guidance Implementation Through Case Study Analysis Recording and Slides	Yang Lu, PhD Senior Staff Fellow DB III | OB | OGD | CDER
Recent Trends in Pharmaceutical Freeze-Drying and Control Strategies Observed in Human Drug Applications and Manufacturing Inspections Recording and Slides	Steve Rhieu, PhD Commander United States Public Health Service Supervisor OPMA | OPQ | CDER
Manufacturing Deficiencies in Liquid Drug Products: The Top Ten Issues Recording and Slides	Allison A. Aldridge, PhD Consumer Safety Officer Division of Pharmaceutical Manufacturing Assessment V (DPMA V) OPMA | OPQ | CDER
Questions & Panel Discussion 8 Recording	Suman Dandamudi, Yang Lu, Steve Rhieu and Allison A. Aldridge
Closing Remarks Recording and Slides	Kendra S. Stewart, RPh, PharmD Captain United States Public Health Service Director Office of Regulatory Operations (ORO) OGD | CDER