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

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

by Elaine Whitmore
     
 

ISBN-10: 0873896130

ISBN-13: 9780873896139

Pub. Date: 12/01/2003

Publisher: ASQ Quality Press

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…  See more details below

Overview

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.

Product Details

ISBN-13:
9780873896139
Publisher:
ASQ Quality Press
Publication date:
12/01/2003
Pages:
224
Sales rank:
1,327,351
Product dimensions:
6.00(w) x 8.90(h) x 0.60(d)

Table of Contents

List of Figures and Tablesix
Forewordxiii
Prefacexv
Preface to Previous Editionxvii
Abbreviationsxix
Part IUnique Challenges in Medical Product Development
Chapter 1Healthcare in the United States3
Chapter 2It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation11
Chapter 3Product Liability and Product Development33
Part IIBringing a New Medical Product to Market
Chapter 4Overview of the Approval Processes for Drugs, Biologics, and Medical Devices43
Chapter 5Designing-in Quality55
Chapter 6Designing-Out Disaster: Risk Analysis63
Chapter 7Recalls, Revocations, and Withdrawals71
Chapter 8Human Factors and the Nature of Relationships: Minimizing Medical Errors77
Chapter 9Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials87
Chapter 10How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care101
Part IIIProduct Development Planning
Chapter 11Models and Metaphors: Product Development and the Product Development Organization109
Chapter 12Components of Product Development Planning: The Product Development Process119
Chapter 13Components of Product Development Planning: Development Portfolio Management131
Chapter 14Components of Product Development Planning: Technology Assessment145
Chapter 15Components of Product Development Planning: Technology Forecasting153
Chapter 16More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality163
Chapter 17Where Do We Go from Here?175
Endnotes179
Glossary183
Resources187
Index195

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