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The FDA Drug Lag: Challenges and opportunities in working with FDA on new drug approvals

18 May 2011


On May 18, 2011, CHI-California Healthcare Institute and Hogan Lovells presented a complimentary seminar that united industry executives, leading life sciences lawyers, and Washington insiders to provide an informed, leading perspective on FDA's "drug lag" and unpredictable drug review standards.  The program provided a high level overview of some of the challenges that small to mid-size pharmaceutical and biotechnology companies face when going through the FDA new drug review and approval process.  It also highlighted the impact that the current regulatory environment is having on biomedical innovation in the United States, including a unique industry perspective, a review of recent drug approval statistics, and a discussion on the impact all of this is having on investment in the biopharmaceutical sector.

Further discussion points included:

  • Are drug reviews really taking longer, and how will PDUFA V impact future reviews?
  • How to Navigate FDA’s Changing Drug Approval Standards and Challenge Unfavorable Agency Decisions
  • Causes of prolonged NDA and BLA reviews
  • Current State of Play with REMS
  • Impact of Drug Review Uncertainty on Funding for Biotech Companies

Included here are the slides from that presentation. Should you have further questions on this topic, please contact one of the Hogan Lovells speakers below.

View the presentation slides (PDF). 


  • Rick E. Winningham, Chief Executive Officer, Theravance, Inc.
  • Beth C. Seidenberg, M.D., Partner, Kleiner Perkins Caufield & Byers
  • Marcea B. Lloyd, Senior Vice President, Government and Corporate Affairs and General Counsel, Amylin Pharmaceuticals
  • Joseph T. Kennedy, Vice President, General Counsel and Secretary, Transcept Pharmaceuticals, Inc.
  • Shelley Chu, M.D., Ph.D., Principal, Frazier Healthcare
  • David L. Gollaher, Ph.D., President and Chief Executive Officer, CHI-California Healthcare Institute
  • Robert F. Church, Partner, Los Angeles, Hogan Lovells
  • Kevin C. Clayton, Partner, Washington, D.C., Hogan Lovells
  • David M. Fox, Partner, Washington, D.C., Hogan Lovells
  • Lynn W. Mehler, Partner, Washington, D.C., Hogan Lovells

San Mateo Marriott
1770 South Amphlett Blvd
San Mateo, CA 94402

18 May 2011

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