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All Lessons

Tissue- and Cell-Derived Therapies: Presentations

Transparency Pilot for Enhanced Communications (Generic Drugs Forum 2025)

Types of Regulatory Submissions (REdI 2024 – Biologics Track)

Understanding OMUFA FY 2024 User Fees and Registration

Unique Device Identifier (UDI) for Patient Safety and Transformation

Update on the ICH E2D(R1) Guideline: Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)

Updates and Current Landscape for Study Population Selection and Additional Mitigation Strategies in Bioequivalence Studies

Updates on the BsUFA Program Research Portfolio  

Use of Real-World Evidence in Accelerated Approval (REdI 2024 – Biologics Track)

User Interface and Human Factor Considerations Around Interchangeability

Using Modeling and Simulation to Correct Carryover for Long Half-Life Drug with Incomplete Washout

USP General Chapters and Outsourcing Facilities (FDA Compounding Conference 2025)

Vendor Perspectives for Dynamic Light Scattering (Particle Size Analysis)

Vendor Perspectives for Laser Diffraction (Particle Size Analysis)

Visual Inspection (FDA Compounding Conference 2025)

Website Orientation

Welcome & Keynote (Advancing Generic Drug Development 2025)

Welcome & Opening Remarks (FDA Compounding Conference 2025)

Welcome & Overview of the Final Rule and the Quality Management System Regulation (REdI 2024 – Devices Track)

Welcome & Presentations (M13B Additional Strengths Biowaiver Guideline)

Welcome and Keynote Address: FDA Cell Therapies and Tissue-Based Products Workshop

Welcome and Opening Remarks (Modeling and AI in Generic Drug Development 2025)

Welcome from NIH (FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA)

Welcome to REdI 2024 Device Track

Welcome, Opening Remarks, and Program Overview (FDA Generic Drug Science Workshop 2025)

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