Commercializing Successful Biomedical Technologies Basic Principles for the Development of Drugs, Diagnostics and Devices
Book contents
- Frontmatter
- Contents
- Foreword by F. L. Douglas
- Preface
- Acknowledgements
- 1 The biomedical drug, diagnostic, and devices industries and their markets
- 2 Markets of interest and market research steps
- 3 Intellectual property, licensing, and business models
- 4 New product development (NPD)
- 5 The regulated market: gateway through the FDA
- 6 Manufacturing
- 7 Reimbursement, marketing, sales, and product liability
- Glossary and acronyms
- Index
- References
5 - The regulated market: gateway through the FDA
Published online by Cambridge University Press: 05 September 2012
Book contents
- Frontmatter
- Contents
- Foreword by F. L. Douglas
- Preface
- Acknowledgements
- 1 The biomedical drug, diagnostic, and devices industries and their markets
- 2 Markets of interest and market research steps
- 3 Intellectual property, licensing, and business models
- 4 New product development (NPD)
- 5 The regulated market: gateway through the FDA
- 6 Manufacturing
- 7 Reimbursement, marketing, sales, and product liability
- Glossary and acronyms
- Index
- References
Summary
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- Type
- Chapter
- Information
- Commercializing Successful Biomedical TechnologiesBasic Principles for the Development of Drugs, Diagnostics and Devices, pp. 172 - 225Publisher: Cambridge University PressPrint publication year: 2008
References
, , , , and, The CE Mark: Understanding the Medical Device Directive, Paton Press, ringbound edn., 1997.Google Scholar
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
(ed.). The Pharmacogenomics Journal, Nature Publishing Group.
and (eds.). FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics, CRC Press, 2004.Google Scholar
(compiler). The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, ASQ Quality Press, 1996.Google Scholar