Skip to content

All Lessons

Download Slides & Transcript (REMS)

Download Webinar Transcript (Bioresearch Monitoring: Electronic Submission Requirements)

Download Webinar Transcript (Certificates of Confidentiality)

Download Webinar Transcript (OMUFA: Understanding FY 2025 User Fees)

Download Workshop Agenda: FDA Generic Drug Science and Research Initiatives Public Workshop 2025

Electronic Submission Gateway (ESG) Modernization: ESG NextGen 

Enhancing Clinical Trial Innovation (REdI 2024 – Drugs Track)

Experiences from Post-Complete Response Letter (CRL) Scientific Meetings in GDUFA III

Exploring Bioequivalence Considerations for Controlled Correspondences: Assessment and Best Practices

Facilitating Development of Gene Therapies for Rare Diseases 

FDA 2024 Animal Drug User Fee Educational Conference – Part 1

FDA 2024 Animal Drug User Fee Educational Conference – Part 2

FDA 2024 Animal Drug User Fee Educational Conference – Part 3

FDA 2024 Animal Drug User Fee Educational Conference – Part 4

FDA 2025 Animal Drug User Fee Educational Conference – Part 1

FDA 2025 Animal Drug User Fee Educational Conference – Part 2

FDA 2025 Animal Drug User Fee Educational Conference – Part 3

FDA 2025 Animal Drug User Fee Educational Conference – Part 4

FDA Cell and Gene Therapy Roundtable (June 2025)

FDA eCTD v4 Implementation Update and CDER NextGen Portal Update

FDA PTP Determination Program, Part 1: Defining Pre-Existing Tobacco ProductNew Lesson

FDA PTP Determination Program, Part 2: Preparing and Submitting a Standalone Pre-Existing Submission

FDA PTP Determination Program, Part 3: Process for Agency Review

FDA Regulation of HIV Tests (REdI 2024 – Biologics Track)

FDA Structure and Mandate (Clinical Investigator Training Course 2024)

1 2 3 4 5 6 … 9
Share: