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The FDA and safety—beyond the heparin crisis

Nature Biotechnology volume 26, pages 621–623 (2008)Cite this article

The discovery of a contaminant in batches of heparin throws into stark relief the difficulties, not only for the US Food and Drug Administration, but also for international regulatory agencies, to ensure the safety and quality of active pharmaceutical ingredients.

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References

  1. Guerrini M. et al. Nat. Biotechnol. advance online publication, doi:10.1038/nbt1407 (23 April 2008).

  2. Kishimoto, T.K. et al. N. Engl. J. Med. published online, doi: 10.1056/NEJMoa0803200 (23 April 2008).

  3. <http://blogs.wsj.com/health/2008/02/27/china-washes-hands-on-heparin-purity/>

  4. <http://abcnews.go.com/Health/wireStory?id=4307873>

  5. <http://www.fas.org/sgp/crs/row/RL34080.pdf>

  6. FDA Science Board Subcommittee on Science and Technology. FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology (US Food and Drug Administration, Rockville, MD, November 2007). <http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf>

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Authors and Affiliations

  1. Cato T. Laurencin is the incoming Vice President for Medical Affairs, Dean of the College of Medicine and Van Dusen Distinguished Professor of Orthopaedic Surgery at the University of Connecticut. He is currently the Lillian T. Pratt Distinguished Professor and Chairman of Orthopaedic Surgery, Professor of Biomedical Engineering and Professor of Chemical Engineering at the University of Virginia. He is also a former member of the National Science Board of the FDA and of the National Science Board's Subcommittee on Science and Technology, which produced the report 'FDA Science and Mission at Risk' in November, 2007. He is currently a member of the National Science Board's Subcommittee studying the FDA's Office of Regulatory Affairs, 400 Ray C. Hunt Drive, Charlottesville, VA 22903, USA. Laurencin@virginia.edu,

    Cato T Laurencin

  2. Department of Orthopaedic Surgery, Lakshmi S. Nair is Assistant Professor of Orthopaedic Surgery, The University of Virginia, 400 Ray C. Hunt Drive, Charlottesville, VA 22903, USA.,

    Lakshmi Nair

Authors
  1. Cato T Laurencin
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  2. Lakshmi Nair
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Laurencin, C., Nair, L. The FDA and safety—beyond the heparin crisis. Nat Biotechnol 26, 621–623 (2008). https://doi.org/10.1038/nbt0608-621

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