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FDA Amendments Act (FDAAA) of 2007: Implementation, Effects on Innovation, and the Impending Debate on "PDUFA V."
Program Code:
3315
Date:
Wednesday, May 20, 2009
Time:
2:00 PM to 3:30 PM
EST
SPEAKER
(S):
Jarilyn Dupont, Director, Regulatory Policy, FDA/Office of Policy/Office of the Commissioner
Andrew Emmett, Biotechnology Industry Organization
Jeffrey Francer, Esq, PhRMA - Pharmaceutical Research & Manufacturers of America
Carolyn Jones, Biogen Idec, Inc
Greg Levine, Esq, Ropes & Gray, LLP
Description
Since the passage of the Food and Drug Administration Amendments Act("FDAAA") in the fall of 2007, FDA has been hard at work implementing the FDAAA's broad array of new statutory authorities and requirements. BIO 2009 will occur at a time when FDA is nearly two years into this process, a useful point at which to take stock of key developments in FDA's implementation of the FDAAA and to debate the "hot button" issues that have arisen. At the same time, the date will be fast approaching when FDA, industry, and other stakeholders are required by law to begin negotiations on the subsequent reauthorization of the Prescription Drug User Fee Act ("PDUFA V").
• Summarize developments in the implementation of the FDAAA
• Understand the effects of FDA's policy choices in implementing the FDAAA on innovation in the biotechnology industry
• Forecast key debating points for PDUFA V and discuss
the political environment in which that legislative debate will occur