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All Lessons

Streamlining Recommendations for Topical and Mucosal Products

The 510(k) Program: Overview and Updates

The Center for Biologics Evaluation and Research (CBER) Bioresearch Monitoring Program

The Journey to Build a Sterile Drug Product Facility

The Role of Controlled Correspondences in Supporting Safety Assessments in Generic Drug Development

Tissue- and Cell-Derived Therapies: Discussion Panel

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)

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