Regulatory Affairs

  • Ronald A. Guido
  • Alan V. McEmber
Part of the Series in Biomedical Engineering book series (BIOMENG)


Drug Development Process Regulator Query Regulatory Affair Clinical Development Program Biotechnology Product 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    Miller, L. L., Cocchetto, David M., “The Regulatory Affairs Professional in the Hot Seat in the Drug Development Process,” Drug Information Journal 31: 805–823, 1997.Google Scholar
  2. 2.
    Omenn, G. S. “Regulatory Frameworks and Decisions Matter to the Development of Biotechnology and the Approvals for Biotechnology Products,” Current Opinion in Biotechnology 10: 287–288, 1999.CrossRefGoogle Scholar
  3. 3.
    Evers, P. “Pharmaceutical Regulatory Affairs Outlook,” Business Insights., 2002.Google Scholar
  4. 4.
    Marasco, C. A. “Careers for 2002 and Beyond: Regulatory Affairs,” Chemical and Engineering News 80(48): 75–80, 2002.CrossRefGoogle Scholar
  5. 5.
    Keramidas, S. “The State of Affairs: An Overview of the Regulatory Affairs Profession,” Science Careers. Novemeber, 2003.Google Scholar
  6. 6.
    Turner, P. “A Career in Product Registration and Regulatory Affairs,” Careers with the Pharmaceutical Industry (second edition): 203–212, 2003.Google Scholar
  7. 7.
    Mantus, D. S. “The Practice of Regulatory Affairs.” FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, The CRC Press, 2004.Google Scholar
  8. 8.
    Carroll, J. “Global Deals Grow; So Do Regulatory Issues,” Biotechnology Healthcare: 9–10. April 2006.Google Scholar
  9. 9.
    Hoag, H. “Rules rule,” Nature 441, 1022–1023, June 2006.CrossRefGoogle Scholar
  10. 10.
    The Tufts Center for the Study of Drug Development,“Outlook 2007,” Impact, April 2007.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2008

Authors and Affiliations

  • Ronald A. Guido
    • 1
  • Alan V. McEmber
    • 1
  1. 1.Global Research and DevelopmentPfizer, Inc.USA

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