Professional development and education

14M157: FDA Update on Safety Issues in the Treatment of Rheumatic Disease

Moderator(s)

• 

  Michael Weisman, MD

  Adjunct Professor of Medicine, Stanford University; Distinguished Professor of Medicine Emeritus, David Geffen School of Medicine at UCLA
  LOS ANGELES, CA, United States

  Disclosure(s): chemocentrix: Consultant (Terminated); novartis: Advisor or Review Panel Member (Terminated); pfizer: Consultant (Terminated); set point: Consultant (Ongoing)

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. The speakers and panel will discuss FDA’s approach to ensuring the availability of safe and effective drugs and highlight new initiatives at FDA. This session will provide an update on new and evolving topics in patient safety, including the regulatory considerations. Further, case studies or examples of interesting regulatory issues or safety issues will be presented.

Presentations:

• 4:30 PM – 4:45 PM Eastern Time

  Update and Safety Issues on Recently Approved Agents for Rheumatic Disease
  

  Speaker: Sabiha Khan, MD – FDA
• 4:45 PM – 5:00 PM Eastern Time

  The Year in Review: Update on Safety Issues at FDA for the Last 12 Months
  

  Speaker: Raj Nair, MD, RhMSUS – Food and Drug Administration
• 5:00 PM – 5:15 PM Eastern Time

  Update From the FDA
  

  Speaker: Suzette Peng, MD – FDA
• 5:15 PM – 5:30 PM Eastern Time

  Panel Discussion
  

  Panelist: Sabiha Khan, MD – FDA

  Panelist: Raj Nair, MD, RhMSUS – Food and Drug Administration

  Panelist: Suzette Peng, MD – FDA

  Panelist: Nikolay Nikolov, MD – FDA