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All Lessons

Clinical Pharmacology: Early Drug Development

ClinicalTrials.gov:  Meeting Transparency and Reporting Requirements 

Closing Remarks (FDA Compounding Conference 2025)

Closing Remarks (Generic Drugs Forum 2025)

Closing Remarks (M13A: Bioequivalence)

Closing Remarks (Navigating Controlled Correspondences)

Closing Remarks (Pre-Sub Meetings)

Closing Remarks (PSG)

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

CMC Considerations for Cell Therapy Characterization: Panel Discussion

CMC Considerations for Cell Therapy Characterization: Presentations

Collaboration, Risk Evaluation, and Surveillance Team (CREST) Site Selection Model Overview

Combination Products – Updates and Best Practices 

Common (OPQ) Deficiencies in Abbreviated New Drug Applications (ANDAs)

Common Bioequivalence (BE) Deficiencies Identified in ANDAs Associated with Solid Oral Extended-Release Drug Products in Various Therapeutic Areas

Common Bioequivalence (BE) Information Requests (IRs): Tips for Facilitating the Review Process

Common Clinical Deficiencies in Abbreviated New Drug Applications (ANDAs) Containing Comparative Clinical Endpoint Studies

Common Deficiencies in Drug Master Files (DMFs)

Common Discrepancies Observed on the Form 356h with the Abbreviated New Drug Application (ANDA) Submission

Comparative Physicochemical Characterization of Iron Products

Compositional Sameness for Complex Polymeric Excipients: Progress and Remaining Challenges 

Compounding Quality Center of Excellence

Consideration Factors for Study Population Selection in Bioequivalence Studies with Pharmacokinetic Endpoints

Considerations for a Revised Risk-Based HCT/P Framework: Discussion Panel

Considerations for a Revised Risk-Based HCT/P Framework: Presentations

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