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Session Information
2007 BIO International Convention
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Drug Safety and PDUFA IV: Overview of Critical Issues in Congress
Track : Regulatory
Program Code: REG040
Date: Wednesday, May 9, 2007
Time: 9:15 AM to 10:45 AM  
Location: 258 A
CHAIR :
Paul T. Kim, Partner, Foley Hoag LLP
SPEAKER (S):
Alison Lawton, Senior Vice President, Regulatory Affairs and Corporate Quality, Genzyme Corporation
 Jeffrey Francer, Assisant General Counsel, Biogen Idec, Inc DC, United States
Description
By September 30, Congress must reauthorize the Prescription Drug User Fee Act to ensure timely reviews of new biotechnology products; at the same time, there is heightened public scrutiny of FDA's assurance of postmarket drug safety. This session will feature thought leaders from industry, FDA and Congress.



Objectives:
  • Provide an outline of the key issues being debated.

  • Offer an expert assessment and discussion of whether PDUFA IV will be reauthorized in a timely manner.

  • Suggest what, if any, new measures Congress might adopt to address drug safety.

    • Streaming Audio with
    PowerPoint Slides
    (Code: REG040)
      
    This session is a part of:
    Regulatory 2-DAY TRACK
    Complete Set of BIO Online / CD-ROM - All 23 Tracks.