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  • Print publication year: 2008
  • Online publication date: September 2012

5 - The regulated market: gateway through the FDA

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References and additional reading
Beck, J. M. and Vale, A.Drug and Medical Device Product Liability Deskbook, Law Journal Press, 2004.
Coenraads, J., Broekhoren, B., Hartmann, S., Tander, H., and, Veldkamp, M.The CE Mark: Understanding the Medical Device Directive, Paton Press, ringbound edn., 1997.
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.
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.
Pisano, D. and Mantus, D. (eds.). FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics, CRC Press, 2004.
Trautman, K. A. (compiler). The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, ASQ Quality Press, 1996.