June 3-4, 2025
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Welcome & Opening Remarks
Session 1: Assessment Challenges with Complex Active Ingredients: Peptides & Oligonucleotides
Session 2: Tackling Formulation Sameness and Advancing In Vitro Characterization for Bioequivalence of Complex Generic Products
Session 3: Future Horizons for Assessing the Bioequivalence of Complex Products: Challenges in the Next Five Years
Session 4: Implementation of the M13A Guidance: Lessons Learned and Advances for Immediate Release Products
Session 5: Challenges and Opportunities for Modified Release Generic Products
Closing Session
About This Course
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) 2026 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. The sessions of this year’s workshop will focus on what research is needed to clarify implementation details and potential guidance recommendations related to, but not limited to:
- Complex active pharmaceutical ingredients, potentially including immunogenicity issues
- Complex products, potentially including inhalation products, complex injectable products, and drug-device combination products
- Oral products, potentially including considerations relevant to ICH M13A, challenges with BCS Class IV drugs, and the feasibility of waiver approaches for modified release products
A common theme across the sessions of the workshop will be to consider what research is needed to overcome challenges for generic product development by establishing approaches that integrate evidence from empirical tests or studies with evidence from computational modeling and simulation. Each session of this year’s workshop will include presentations and a panel discussion with representatives from the generic drug industry, academia, and FDA.