FDA Corner
Nov
16
2024
Convention Center: Ballroom 6B
11:00 AM - 12:30 PM
Description
The purpose of this forum is to provide attendees insight into how the Division of Hepatology and Nutrition executes its regulatory mission to facilitate development of safe and effective products to treat non-viral liver disease. This session will focus on how new legislation may impact drug development for non-viral liver diseases, as well as major regulatory events which occurred within the Division from the period September 1, 2023 – August 31, 2024.Presentations
11:00 AM - 11:05 AM
Nov
16
2024
San Diego, CA
Introduction
Frank A Anania, MD, FAASLD, FACP, AGAF, Moderator
11:05 AM - 11:25 AM
Nov
16
2024
San Diego, CA
Agency Review of Resmetirom: Considerations for the Evaluation of Efficacy & Safety
Ashish Dhawan, MD, MSPH, Presenter
11:25 AM - 11:40 AM
Nov
16
2024
San Diego, CA
Approach to Agency Approval of Resmetirom: Benefit:Risk & Labeling
Gerri Baer, MD, Presenter
11:40 AM - 11:55 AM
Nov
16
2024
San Diego, CA
FDORA Legislation Impact in Liver Diseases: Increasing diversity in trials & updates to the accelerated approval pathway
George Makar, MD, MSCE, Presenter
11:55 AM - 12:30 PM
Nov
16
2024
San Diego, CA
Q&A Session and Closing
Frank A Anania, MD, FAASLD, FACP, AGAF, Moderator
Objectives
- Review efficacy and safety considerations in the approval of resmetirom (REZDIFFRA) in the context of surrogate endpoints and the Accelerated Approval pathway
- Describe how the provisions in the Food and Drug Administration Omnibus Reform Act (FDORA) of 2022 to increase diversity in clinical trials and modify the Accelerated Approval pathway may impact drug development for liver diseases
- Identify the role of the Accelerated Approval pathway and the requirements for drug products that have undergone accelerated approval to demonstrate clinical benefit in the post-market setting for liver diseases
- Discuss the role of surrogate endpoints in Approval pathways for new drug products for liver diseases