American Heart Journal
Volume 157, Issue 5 , Pages 825-826 , May 2009

New precompetitive paradigms: Focus on cardiac safety

  • John Finkle, MD

      Affiliations

    • Global Clinical Safety and Pharnacovigilance, GlaxoSmithKline, Collegeville, PA
    • ,
  • Daniel Bloomfield, MD

      Affiliations

    • Cardiovascular Clinical Research, Merck Research Laboratories, Merck and Co., Inc, Rahway, NJ
    • ,
  • Kathleen Uhl, MD

      Affiliations

    • Office of Woman's Health, US Food and Drug Administration, Rockville, MD
    • ,
  • Wendy Sanhai, PhD

      Affiliations

    • Office of the Commissioner, US Food and Drug Administration, Rockville, MD
    • ,
  • Norman Stockbridge, MD

      Affiliations

    • Office of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
    • ,
  • Mitchell W. Krucoff, MD

      Affiliations

    • Department of Medicine, University Medical Center, Durham, NC

Received 23 February 2009 ,Accepted 24 February 2009.

References 

  1. Challenge and opportunity on the critical path to new medical products, March 2004. Available at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.htmlLast accessed March 24, 2009
  2. CDER drug and biologic approval report. Available at http://www.fda.gov/Cder/rdmt/default.htmLast accessed March 24, 2009
  3. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med. 2008;358:1354–1361

PII: S0002-8703(09)00155-0

doi: 10.1016/j.ahj.2009.02.021

American Heart Journal
Volume 157, Issue 5 , Pages 825-826 , May 2009

Article Tools