Skip to main content

Part of the book series: Series in Biomedical Engineering ((BIOMENG))

  • 1571 Accesses

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Bibliography

  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. 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.

    Article  Google Scholar 

  3. Evers, P. “Pharmaceutical Regulatory Affairs Outlook,” Business Insights., 2002.

    Google Scholar 

  4. Marasco, C. A. “Careers for 2002 and Beyond: Regulatory Affairs,” Chemical and Engineering News 80(48): 75–80, 2002.

    Article  Google Scholar 

  5. Keramidas, S. “The State of Affairs: An Overview of the Regulatory Affairs Profession,” Science Careers. Novemeber, 2003.

    Google Scholar 

  6. Turner, P. “A Career in Product Registration and Regulatory Affairs,” Careers with the Pharmaceutical Industry (second edition): 203–212, 2003.

    Google Scholar 

  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. Carroll, J. “Global Deals Grow; So Do Regulatory Issues,” Biotechnology Healthcare: 9–10. April 2006.

    Google Scholar 

  9. Hoag, H. “Rules rule,” Nature 441, 1022–1023, June 2006.

    Article  Google Scholar 

  10. The Tufts Center for the Study of Drug Development,“Outlook 2007,” Impact, April 2007.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2008 Springer Science+Business Media, LLC

About this chapter

Cite this chapter

Guido, R.A., McEmber, A.V. (2008). Regulatory Affairs. In: Madhavan, G., Oakley, B., Kun, L. (eds) Career Development in Bioengineering and Biotechnology. Series in Biomedical Engineering. Springer, New York, NY. https://doi.org/10.1007/978-0-387-76495-5_18

Download citation

  • DOI: https://doi.org/10.1007/978-0-387-76495-5_18

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-0-387-76494-8

  • Online ISBN: 978-0-387-76495-5

  • eBook Packages: EngineeringEngineering (R0)

Publish with us

Policies and ethics