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5 - The regulated market: gateway through the FDA

Published online by Cambridge University Press:  05 September 2012

Shreefal S. Mehta
Shreefal S. Mehta
Affiliation:
Cytopia
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Commercializing Successful Biomedical Technologies
Basic Principles for the Development of Drugs, Diagnostics and Devices
 , pp. 172 - 225
Publisher: Cambridge University Press
Print publication year: 2008

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References

Beck, J. M. and Vale, A.Drug and Medical Device Product Liability Deskbook, Law Journal Press, 2004.Google Scholar
Coenraads, J., Broekhoren, B., Hartmann, S., Tander, H., and, Veldkamp, M.The CE Mark: Understanding the Medical Device Directive, Paton Press, ringbound edn., 1997.Google Scholar
Harnack, G.Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration, ASQ Quality Press, 1999.Google Scholar
Licinio, J. (ed.). The Pharmacogenomics Journal, Nature Publishing Group.
Pines, W. L. (ed.). How to Work With the FDA, Food and Drug Law Institute, 2nd edn., 2003.Google Scholar
Pisano, D. and Mantus, D. (eds.). FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics, CRC Press, 2004.Google Scholar
Trautman, K. A. (compiler). The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, ASQ Quality Press, 1996.Google Scholar

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