Workshop | Mixed
Event Title
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop
June 8 - 9, 2026
- Date:
- June 8 - 9, 2026
- Day1:
- Mon, Jun 8
- Day2:
- Tue, Jun 9
About This Workshop
On this page
The purpose of this annual public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties, as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) science and research priorities.
Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and regulatory assessment of generic products, including complex generics. During the workshop, public input will also be sought on the prioritization of product-specific guidances (PSGs). The sessions of this year’s workshop will focus on identifying what research is needed related to:
- Leveraging Generic Drug Industry Expertise & Insights for GDUFA Research & PSG Prioritization
- Addressing Ongoing Challenges with Impurities such as Nitrosamines
- Expanding Regulatory Flexibility with Bioequivalence Approaches and Standards
- Using Artificial Intelligence (AI) to Address Practical Challenges for Generic Drug Development and Regulatory Assessment
- Standardizing Characterization Test Methods Supporting Bioequivalence and Product Quality
Audience
Members of the public including those involved with the generic drug industry, scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs are welcome to attend.
FDA wants your input
FDA seeks ideas on generic drug research topics from the public, the generic drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the FY 2027 research priorities for generic drugs. You may submit your ideas for potential topics for the FY 2027 GDUFA Science and Research Priorities by submitting a comment to the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of July 10, 2026.
Workshop Recordings and Presentations
Presentations
Opening Remarks, Office of Generic Drugs (PDF – 1.5 MB)
Darby Kozak, PhD
Deputy Director, OGD, CDER, FDA
Opening Remarks, Office of Pharmaceutical Quality (PDF – 1.4 MB)
Sau (Larry) Lee, PhD
Deputy Director of Pharmaceutical Quality, OPQ, CDER, FDA
Overview of the GDUFA Science and Research Program (PDF – 657 KB)
Robert Lionberger, PhD
Director, ORS, OGD, CDER, FDA
Part 1
Part 2
Presentations
Nitrosamines in Drugs: A Regulatory Perspective on Research Progress and Opportunities (PDF – 1.1 MB)
Robert Dorsam, PhD
Division Director, DPTR, OSCE, OGD, CDER, FDA
Overview of HESI Program and Research Initiatives (PDF – 4.3 MB)
Joel Bercu, PhD, MPH, DABT
Executive Director, Gilead Sciences
Using In Vivo Transgenic Rodent (TGR) Data to Evaluate Mutagenic Potency (PDF – 200 MB)
Robert Jolly, CPH, MPH, DABT
Senior Advisor, Risk Assessment, Toxicology, Lilly Research Labs
Deriving Scientifically Sound Acceptable Intake Limits for N‑Nitroso‑Bisoprolol by using Error‑Corrected Sequencing (ECS) and Benchmark Dose (BMD) Analysis of In Vivo Mutagenicity Data – from Hazard Identification towards Human Risk Assessment (PDF – 1 MB)
Stephanie Simon, PhD, ERT
Senior Toxicologist, Associate Scientific Director, Merck (EMD Serono)
Nitrosamine Mitigation Strategies: Insights from the FDA and Emerging Challenges (PDF – 1.3 MB)
Diaa Shakleya, PhD
Senior Research Scientist, DPQR V, OPQR, OPQ, CDER, FDA
Antioxidants in Nitrosamine Risk Mitigation: Challenges and Considerations (PDF – 766 KB)
Valerie Niddam-Hildesheim, PhD
Senior Director, Global Nitrosamine Project Lead, Teva Pharmaceuticals
Cracking the NDSRI Code: Mitigation in Generic Drugs, a Mission impossible? (PDF – 791 KB)
Filip Geert A De Bock, PhD
Global Center of Excellence for Mutagenic Impurities Lead, Sandoz
Analytical Methods for NDSRIs: Challenges & Troubleshooting (PDF – 575 KB)
Houri Simonian, PhD
Senior Director, Analytical Research and Development, Apotex
Nitrosamine Risk of Recovered Solvents & NOx as Nitrosating Agent (PDF – 4.6 MB)
Joerg Schlingemann, MB, PhD
Director, Global Quality Control Principal Expert, Merck (EMD Serono)
The Role of Excipients in Nitrosamine Risk Mitigation: Nitrite Control and Scavengers (PDF 1.2 MB)
Ulrich Reichert, PhD, MDRA
Head of CDMO & Bioprocess Materials, Reg. Mgmt., Merck (MiliporeSigma)
Ongoing Challenges with Nitrosamines Impurities Public Comment Presentations
Other N-nitroso compounds (PDF – 674 KB)
Raphael Nudelman, Ph.D., ERT
CEO, Nudelman ChemTox Consulting
Using In Vivo Mutation Data for Risk Assessment of Nitrosamine Impurities (PDF – 1.2 MB)
George Johnson, PhD
Associate Professor, Swansea University
VICT3R Virtual Control Groups. Towards Qualification and Regulatory Acceptance (PDF – 2.6 MB)
Frank Bringezu, PhD
Associate Director Chemical & Preclinical Safety, EMD Serono
Part 1
Part 2
Presentations
AI and FDA’s Inactive Ingredient Database (PDF – 821 KB)
CDR Diana Solana-Sodeinde, PharmD
Lead Program Coordinator, OB-IO, OGD, CDER, FDA
Development of an AI Automation Tool to Facilitate Maximum Daily Dose Determination (PDF – 768 KB)
Jing (Jenny) Wang, PhD
Staff Fellow, DQMM, ORS, OGD, CDER, FDA
Artificial Intelligence: Key to Address Practical Challenges for Generic Drugs (PDF – 2.7 MB)
Arti Patel, MS
Senior Manager, Cosette Pharma
AI/ML and Data Enablement in Generic Drug Manufacturing (PDF – 528 KB)
Jeremy Evans, PhD
Director, AI/ML Innovation in Pharmaceutical Manufacturing, USP
GenAI Opportunity to De-risk and Accelerate Generic Product Development (PDF –1.5 MB)
Tushar Nitave, MS
Staff Software Engineer, Vivpro Corp.
AI-Assisted Generic Formulation and Nitrosamine Risk: Algorithmic Workflows (PDF – 2.6 MB)
Sandip Tiwari, PhD
Head of Technical Services, BASF
Using AI to Address Practical Challenges for Generic Drugs: Using Digital Twins to Serve as RLD (PDF – 1.2 MB)
Brooke Langevin, PhD
Assistant Professor, University of Maryland, Baltimore
AI/ML Regulatory Perspectives: Challenges and Considerations (PDF – 4.2 MB)
Geng Tian, PhD
Supervisory Research Officer, DPQR VI, OPQR, OPQ, CDER, FDA
Advancing Pharmaceutical Quality System Assessment to Support ICH Q12 Implementation: Leveraging Evidence-Based AI Tools (PDF – 1 MB)
Torrey Ward
Consumer Safety Officer, DQI-II, OQS, OPQ, CDER, FDA
Presentation
Recent Developments and Experiences with Utilization of Non-Standard In-Vitro Characterization Tools to Demonstrate Bioequivalence between Reference and Test Drug Device Combination Products (PDF – 2.7 MB)
Abhishek (Abhi) Gupta, PhD
Chief Scientific Officer, Transpire Bio
Presentations
Characterizing the Complex: Validating Non-Compendial Methods, Comparing Q3, and Setting Acceptance Criteria for Complex Generic Drug Products (PDF – 258 KB)
Brock Roughton, PhD
Division Director, DPQA XI, OPQAII, OPQ, CDER, FDA
QMM as a Framework for Driving Operational Performance and Business Excellence (PDF – 1.4 MB)
Eric Twum, PhD
Regulatory Specialist, DQI-II, OQS, OPQ, CDER, FDA
Public Comment Presentations
Integrating LLM-Based "Pre-Submission" Audits to Mitigate First-Cycle ANDA Deficiencies (PDF – 2.7 MB)
Raghu Ram Pannala, PhD
Sciegen pharmaceuticals Inc
Master of Masters: Model Master Fine in Generic Space & Requirement for Recovering BSV and WSV of PK (PDF – 2.3 MB)
Amin Rostami-Hodjegan, PhD
Senior Vice-President of R&D and CSO, Certara Inc,
Professor of Systems Pharmacology, University of Manchester, UK
When Simple Isn’t Enough. Mechanistic PBPK and Virtual Bioequivalence as Enablers of Bio-Waivers (PDF – 683 KB)
Maitri Sanghavi, MS
Research Scientist, Certara
Model Integrated Bioequivalence (MIBE) in Generic Research: Case Examples, Future Research (PDF – 1.4 MB)
Sivacharan Kollipara, PhD
Vice President & Head, Biopharmaceutics, Dr.Reddy’s Laboratories Ltd
Generic Autoinjectors & Intranasal Rescue Devices: Real-World Emergency Use Considerations (PDF – 1 MB)
Amy Lukau, PhD
Founder and Principal, Kimpasi Inc.
Applied Solutions to Overcome the Challenges Associated with Spray Dried Powders in Generic Orally Inhaled and Nasal Drug Products Development (PDF – 1.8 MB)
Irene Rossi, PhD
Respiratory Science Expert, Harro Höfliger
Human-Relevant New Approach Methodologies (NAMs) for Nasal Drug Delivery to the CNS (PDF – 1.4 MB)
Laleh Golshahi, PhD
Associate Professor, Virginia Commonwealth University
Founder & CEO, 3DInhale
Standardizing Characterization Test Methods Supporting Bioequivalence and Product Quality: PLGA/PLG (LG Polymer) Nomenclature and Quality Test Methods (PDF – 1.1 MB)
Peng Zhang, PhD
Principal Scientist-Excipients, USP
Panel Discussion
Illustration (PDF – 164 KB)