Date: May 20 – 21, 2024 Day1: Mon, May 20 Day2: Tue, May 21

About This Workshop

The purpose of the 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) 2025 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. Sessions of the FY 2024 GDUFA Public Workshop will facilitate public input on research needs for generic products, including those related to:

Nitrosamine Drug Substance-Related Impurities
Drug-Device Combination Products
Predictive Tools to Improve the Efficiency of Generic Product Development
Other Research Needed to Address GDUFA III Science & Research Priority Initiatives

Audience

Members of 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.

FDA Wants Your Input

FDA seeks ideas on generic drug research topics from the generic drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the FY 2025 science and research priorities for generic drugs. You may submit your ideas for potential topics for the FY 2025 GDUFA Science and Research Priorities by submitting a comment on the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of June 21, 2024.

Workshop Recordings

Session 1: Nitrosamine Drug Substance-Related Impurities (NDSRIs)

Session 2: Predictive Tools for Generic Product Development and Assessment

Session 3: Public Comments

Session 4: Drug-Device Combination Products

Presentations

Opening Remarks

Session 1: Nitrosamine Drug Substance-Related Impurities (NDSRIs)

Public Comment Presentations on NDSRIs (PDF – 2.73 MB)
N-Nitrosamine SAR Modeling of Potency – Current Status and Future Needs (PDF – 1.24 MB)
Kevin P. Cross, PhD
VP, Regulatory Science, PI, FDA Research Collaborations, Instem
N-Nitrosamine Drug Impurity Research at FDA/NCTR: Assessing the Mutagenicity of N-Nitrosamines and NDSRIs (PDF – 1.56 MB)
Xilin Li, PhD
Visiting Scientist, DGMT, NCTR, FDA
NDMA and Beyond: A Biased Kinetic Model to Assess Nitrosation Risk in Solid Drug Products (PDF – 1.56 MB)
Dr. Ian W. Ashworth
Principal Scientist, Chemical Development, AstraZeneca, Macclesfield, UK
CMC Considerations and Bridging Bioequivalence Studies of Reformulated Products Impacted by Nitrosamines (PDF – 739 KB)
Martin Ehlert, PhD
Vice-president, API R&D, Apotex Inc.
Physiologically Based Pharmacokinetic Absorption Modeling to Support BCS Based Waiver of In Vivo BE Studies (PDF – 623 KB)
Fang Wu, PhD
Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA
Nitrosamine Impurities: Beyond a Compendial Standard – Learnings from USP’s Nitrosamines Exchange Community (PDF – 3.37 MB)
Naiffer Romero, MSc, MPH
Principal Scientist, Scientific Affairs – US Pharmacopeia

Session 2: Predictive Tools for Generic Product Development and Assessment

Public Comment Presentations on Predictive Tools for Generic Product Development and Assessment (PDF – 25.8 MB)
Advancing the Use of Model-Integrated Evidence in Generic Drug Development and Assessment (PDF – 579 KB)
Liang Zhao, PhD
Director, DQMM, ORS, OGD, CDER, FDA
Integration of Simulation, In Vitro and Clinical Methods to Support Complex Drug Product Development (PDF – 0.99 MB)
William Ganley, PhD
Senior Specialist, Nanopharm Ltd. (an Aptar Pharma company)
PBPK Modeling of Locally Acting Drug Products: Identifying and Addressing Factors Affecting Extrapolation (PDF – 2.3 MB)
Jessica Spires, PhD
Principal Scientist, Simulation Plus
Digital Twins and In-silico Trials to Support the Approval Process of Complex Generics (PDF – 10.7 MB)
Jan de Backer, PhD, MBA
Chief Executive Officer, Fluidda

Session 3: Public Comments

Session 4: Drug-Device Combination Products

Public Comment Presentations on Drug Device Combination Products (PDF – 835 KB)
Comparative Use Human Factors Studies: Challenges and Recommendations (PDF – 1.25 MB)
Brandon Wood, BS
Director of Regulatory Affairs, Generic Steriles (Teva Pharmaceuticals USA, Inc.)
We Muddled Our Way Through the CUHF Process, Now What Does It Mean? (PDF – 1.27 MB)
Melissa Lemke, MS
Regulatory Human Factors Engineering Advisor, Human Ability Designs, LLC
Comparative Threshold Analysis – So Near, Yet So Far … (PDF – 337 KB)
Vivek Viswanathan, PhD
Manager, Research & Development, Rubicon Research Canada Ltd.
and
Daliya Bharati, MS
Director, Regulatory Affairs and Intellectual Property, Advagen Pharma, Ltd.
Industry Perspective: Development of Generic Emergency Use Products (PDF – 4.83 MB)
Amy Lukau, BA, BS
Senior Human Factors Lead, Kindeva Drug Delivery
It’s Hip to be Square: Demonstrating Equivalency without Inferiority in CUHF Studies (PDF – 0.98 MB)
Heidi Mehrzad, MS
CEO and Human Factors Expert, HFUX Research, LLC