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All Lessons

Specific Populations in Clinical Trials

Specific Populations in Clinical Trials

Stability Studies and Validation (FDA Compounding Conference 2025)

Standardized Format for Electronic Submission of NDA and BLA Content for BIMO Inspections for CDER Submissions

Statistical Principles for Clinical Development

Step 1: Learn And Do

Step 2: Learn And Do

Step 3: Learn And Do

Step into the Closing Meeting: Navigating an FDA Closeout and Beyond (REdI 2024 – Devices Track)

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 on the BsUFA Program Research Portfolio  

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

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

Visual Inspection (FDA Compounding Conference 2025)

Website Orientation

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