FDA to Review New Rheumatology Approvals, Safety Messaging, Programs

Get set for what may be one of the most popular returning programs of ACR Convergence, the annual U.S. Food and Drug Administration (FDA) update session. Three top leaders from the agency’s Division of Rheumatology and Transplant Medicine (DRTM) will present the FDA Update on Safety Issues in the Treatment of Rheumatic Diseases on Saturday, Nov. 16, from 1–2:30 p.m. ET in Hall D/E of the Walter E. Washington Convention Center.

Eric Gapud, MD, PhD, DRTM Clinical Team Leader, will provide a comprehensive review of new drug approvals in the past year relevant to the rheumatology community, including new treatments for eosinophilic granulomatosis with polyangiitis (EGPA), psoriatic arthritis (PsA), and polyarticular juvenile idiopathic arthritis (pJIA) and other indications.

Timely communication of evolving safety information is a critical element in the ability of practitioners to provide the best care for their patients with rheumatic diseases. In addition to recent new drug approvals relevant to rheumatology, speakers will discuss the FDA’s current approach to ensuring the availability of safe and effective drugs and highlight new initiatives.

“I will be discussing new initiatives and programs at the FDA that impact drug development and may be of interest to the rheumatology community,” said DRTM Clinical Reviewer Austin Anderson, DO. “My presentation will focus on the use of artificial intelligence (AI) and machine learning in drug development and provide some key considerations on the use of AI from a regulatory perspective.”

This annual session will also provide an update on new and evolving topics in patient safety, including the latest in regulatory considerations. Amit Golding, MD, PhD, also a DRTM Clinical Team Leader, will give an overview of safety issues that are important and relevant to rheumatologists and to their patients, including safety labeling changes and safety communications that have occurred over the past 12 months.

“This is an important opportunity for the FDA to interact directly with the rheumatology community, including clinicians, the academic rheumatology community, and industry,” Dr. Golding said. “In addition to providing a public presentation of the work we do, this is our opportunity to talk directly with the rheumatology community about important issues that are on their minds.”