Skip to content

All Lessons

Extrapolation of PK Bioequivalence to an Alternative Comparator due to RLD/RS Unavailability

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 Dissolution Methods and Navigating the Dissolution Database

FDA eCTD v4 Implementation Update and CDER NextGen Portal Update

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

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)

FDA Welcome and Keynote (REdI 2024 Conference)

FDA’s Good Clinical Practice Compliance Review for NDAs and BLAs

FDA’s M13A Implementation for Generic Drug Applications: Focus on PSG Revisions (Additional M13A and Other Revisions)

FDA’s M13A Implementation for Generic Drug Applications: PSG Revisions to Align with M13A

FDA’s Use of Alternative Approaches to Evaluate GCP Compliance

Fiscal Year 2025 OMUFA Fee Schedule

Foundations of Medical Device Regulation in a World of Change

1 … 5 6 7 8 9 … 16
Share: