Session Information
2009 BIO International Convention
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FDA Science and Mission at Risk
Track : Achieving Regulatory Approval
Program Code: 2785
Date: Monday, May 18, 2009
Time: 4:00 PM to 5:30 PM  EST
Location: B315
SPEAKER (S):
Gail Cassell, PhD, Eli Lilly & Company
Peter Hutt, Esq, Covington & Burling LLP
Robert Nerem, PhD, Georgia Institute of Technology
Description
In a November 2007 report "FDA Science and Mission at Risk," an adhoc special subcommittee appointed by the FDA Science Board made the case that the FDA cannot fulfill its mission because its scientific base has eroded, its organizational structure is weak, its scientific workforce does not have sufficient capacity and capability, and its information technology infrastructure is inadequate. Since the report was released, funding for FDA has increased and some organizational changes have been made. This panel will provide an overview of the findings of the subcommittee,
assess the progress that has been made to date and share next steps for continued evolution at FDA.

• Provide an overview of the limitations and challenges facing FDA in the 21st century
• Assess the progress made over the past 18 months to enable FDA to regulate next generation biomedical technologies
• Share a window into future improvements that are needed for FDA


Audio Synchronized to PowerPoint
(Code: 2785)
  
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