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All Lessons

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

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

Session 5A: Question & Answer Panel (Advancing Generic Drug Development 2024)

Session 5A: Spotlight Generic Drug Review Challenges and Solutions

Session 5B: Question & Answer Panel (Advancing Generic Drug Development 2024)

Session 5B: Spotlight Generic Drug Review Challenges and Solutions

Session 6: Ensuring Efficient and Consistent High Quality Generic Drug Development

Session 6: Question & Answer Panel (Advancing Generic Drug Development 2024)

SME Triage Team Case Study: Complex Implant Products – Excipient Sameness, Characterization and Bioequivalence Challenges

SME Triage Team: Office of Pharmaceutical Quality Research & Office of Research and Standards Product-Specific Guidance Development

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)

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

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