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All Lessons

Session 3: Panel Discussion (FDA Generic Drug Science Workshop 2025)

Session 3: Presentations (FDA Generic Drug Science Workshop 2025)

Session 4: Panel Discussion (FDA Generic Drug Science Workshop 2025)

Session 4: Presentations (FDA Generic Drug Science Workshop 2025)

Session 5: Panel Discussion (FDA Generic Drug Science Workshop 2025)

Session 5: Presentations (FDA Generic Drug Science Workshop 2025)

Specific Populations in Clinical Trials

Specific Populations in Clinical Trials

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

Transparency Pilot for Enhanced Communications (Generic Drugs Forum 2025)

Types of Regulatory Submissions (REdI 2024 – Biologics Track)

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)

Website Orientation

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

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