Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices / Edition 2

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Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. This revised edition includes: updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. The author also covers the Food and Drug Administrations Modernization Act (FDAMA), along with discussions on Intellectual Property, Pharmacoeconomics, and Technological and Medical Trends.
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Product Details

  • ISBN-13: 9780873896139
  • Publisher: ASQ Quality Press
  • Publication date: 12/1/2003
  • Edition number: 2
  • Pages: 224
  • Sales rank: 1,298,064
  • Product dimensions: 6.00 (w) x 8.90 (h) x 0.60 (d)

Table of Contents

List of Figures and Tables ix
Foreword xiii
Preface xv
Preface to Previous Edition xvii
Abbreviations xix
Part I Unique Challenges in Medical Product Development
Chapter 1 Healthcare in the United States 3
Chapter 2 It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation 11
Chapter 3 Product Liability and Product Development 33
Part II Bringing a New Medical Product to Market
Chapter 4 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices 43
Chapter 5 Designing-in Quality 55
Chapter 6 Designing-Out Disaster: Risk Analysis 63
Chapter 7 Recalls, Revocations, and Withdrawals 71
Chapter 8 Human Factors and the Nature of Relationships: Minimizing Medical Errors 77
Chapter 9 Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials 87
Chapter 10 How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care 101
Part III Product Development Planning
Chapter 11 Models and Metaphors: Product Development and the Product Development Organization 109
Chapter 12 Components of Product Development Planning: The Product Development Process 119
Chapter 13 Components of Product Development Planning: Development Portfolio Management 131
Chapter 14 Components of Product Development Planning: Technology Assessment 145
Chapter 15 Components of Product Development Planning: Technology Forecasting 153
Chapter 16 More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality 163
Chapter 17 Where Do We Go from Here? 175
Endnotes 179
Glossary 183
Resources 187
Index 195
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