Session Information
2009 BIO International Convention
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Preemption of Product Liability Litigation on FDA- Regulated Products
Track : Legal Issues
Program Code: 3479
Date: Tuesday, May 19, 2009
Time: 2:00 PM to 3:30 PM  EST
Location: B303
SPEAKER (S):
Sandra Dennis, Biotechnology Industry Organization
Erika Lietzan, Covington & Burling LLP
Gerry Masoudi, U.S. Food and Drug Administration
Paul Schmidt, Esq, Covington & Burling LLP
Brain Wolfman
Description
Over the last two years, the Supreme Court has taken preemption three times in the context of drugs and devices; Congress has been active on this topic; and the topic has received a high level of media coverage. This panel will review the core Supreme Court and lower court cases, Congress and FDA's responses to this issue, and what this means in today's biopharmaceutical environment, and will discuss the implications of these decisions in current and future product liability cases.

• Provide an understanding of the recent court rulings on preemption of FDA-regulated products
• Provide an understanding of related FDA policies on drug labeling
• Provide an understanding of potential congressional actions relating to preemption


Audio Synchronized to PowerPoint
(Code: 3479)
  
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