Skip to content

All Lessons

Certificates of Confidentiality: General Overview

Chemistry, Manufacturing and Controls: Regulatory Considerations Through Clinical Development

Clinical Investigator Inspection Readiness

Clinical Pharmacology: Early Drug Development

ClinicalTrials.gov:  Meeting Transparency and Reporting Requirements 

Closing Remarks (Generic Drugs Forum 2025)

Closing Remarks (M13A)

Closing Remarks (Navigating Controlled Correspondences)

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

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

Considerations when Submitting Proposed Excipient Levels in Inactive Ingredient Controlled Correspondences

Controlled Correspondence on Clinical Pharmacology Topics in Generic Drug Development

Course Feedback 

Cross-Comparison to Other Drug Master Files and Lessons Learned  

Day 1, Session 1 Q&A (Clinical Investigator Training Course 2024)

Day 1, Session 1 Q&A (Generic Drugs Forum 2025)

Day 1, Session 2 Q&A

Day 1, Session 2 Q&A (Clinical Investigator Training Course 2024)

Day 1, Session 2 Q&A (Generic Drugs Forum 2025)

1 2 3 4 … 9
Share: