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Model-Integrated Evidence for Generic Drug Development – Session 1B
Model-Integrated Evidence for Generic Drug Development – Session 1A
Model-Integrated Evidence for Generic Drug Development – Session 1C
Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 2
Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop
Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks
Dr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020
Global Generic Drug Landscape
Developing and Implementing Science-Based Standards in Bioequivalence Assessment
Non-Complex Drug Products and Product-Specific Guidances
Strategic Implementation of Model-informed Drug Development (MIDD) for Regulatory Success
Product-Specific Guidance Fundamentals from a Clinical Perspective
