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Medical Devices and the Public's Health The FDA 510(k) Clearance Process at 35 Years (2011) / Chapter Skim
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Appendix B: Committee Biographies
Pages 279-286

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From page 279...
... Louis University School of Medicine from 1975 to 1982 and as the University of Florida vice president for health affairs and chairman of the Board of Directors of Shands Health Care from 1982 to 1998. He is a member of the Institute of Medicine (IOM)
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From page 280...
... Earlier in her career, she was a partner in the international regulatory practice of a large New York law firm and advised clients on US medical-device regulatory matters. She holds a bachelor's degree in electrical engineering from the University of Texas at Austin, an MS in applied earth science and a PhD in earth sciences from Stanford University, a JD from Yale Law School, and an LLM in health law from the University of Houston, and she completed a postdoctoral fellowship in clinical ethics at the M.D.
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From page 281...
... He represented the FDA on the Clinical Laboratory Improvement Amendment Committee, the Department of Health and Human Service's Secretary's Advisory Committee on Genomics, Health and Society (SACGHS) , and the Member of the International Standards Organization Technical Committee for Laboratory Tests (ISO-TC 212)
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From page 282...
... Dr. Korn served as Carl and Elizabeth Naumann Professor and dean of the Stanford University School of Medicine from October 1984 to April 1995, and as vice president of Stanford University from January 1986 to April 1995.
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From page 283...
... She was founder and director of Howard University's Center for Research in Evaluating Software Technology and was a visiting scientist of the City University (London) Centre for Software Reliability, principal scientist of MITRE Corporation's Software Engineering Center, and manager of the measurement program of the Contel Technology Center.
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From page 284...
... She has received numerous awards, including the BioPharm Person of the Year Award in 1992, the NIH Lectureship in 1994, the Sydney Riegelman Lectureship in 1994, the Genetic Engineering News Award for streamlining and improving the regulatory process for biologics and biotechnology products in 1994, the Meritorious Executive Rank Award for sustained superior performance in revitalizing and reorganizing the CBER to meet the challenges of new responsibilities and new technologies in 1994, the National Cancer Patients Grateful Patients Award in 1996, the Rens
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From page 285...
... Dr. Zoon received a PhD in biochemistry from the Johns Hopkins University.
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Key Terms

  • interventional radiology
  • professor wolfman
  • law school
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  • supreme court

  • clinical trials
  • laboratory tests
  • georgetown law
  • clinical laboratory
  • health law

  • indiana university
  • law firm
  • radiological society
  • appellate courts
  • diagnostic devices

  • software engineering
  • university law
  • cancer institute
  • grateful patients
  • malaria vaccine

  • transitional science
  • barbara evans
  • investigative pathology
  • cardiac implant
  • earth sciences

  • sustained superior
  • beaumont award
  • naumann professor
  • patients grateful
  • registry findings


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