FDA Update on Safety Issues in the Treatment of Rheumatic Diseases

Moderator(s)

• 

  Arthur Kavanaugh, MD

  UCSD

Speaker(s)

• RN

  Raj Nair, MD

  Food and Drug Administration
• 

  Amit Golding, MD, PhD

  Food and Drug Administration
• NN

  Nikolay Nikolov, MD

  FDA

Timely communication of evolving safety information is a critical element in the ability of practitioners to provide the best care for patients with rheumatic diseases. At this session, the panel will discuss the 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 late-breaking or evolving topics in patient safety, including any relevant FDA analysis or response to these issues. In addition, case studies or examples of interesting regulatory issues or safety issues will be presented.

Learning Objectives:

• Identify important safety issues in recently approved agents for the treatment of rheumatic diseases
• Integrate knowledge of new safety issues into treatment strategies
• Review ways to more fully advise patients about the safety issues related to treatments for rheumatic diseases

Presentations:

• 10:00 AM – 10:15 AM ET

  Update & Safety Issues on Recently Approved Agents for Rheumatic Disease
  Raj Nair, MD – Food and Drug Administration
• 10:15 AM – 10:30 AM ET

  The Year in Review: Update on Safety Issues at FDA for the Last 12 Months
  Amit Golding, MD, PhD – Food and Drug Administration
• 10:30 AM – 10:45 AM ET

  Update from the FDA
  Nikolay Nikolov, MD – FDA
• 10:45 AM – 11:00 AM ET

  Q&A