Development of FDA-Regulated Medical Products Prescription Drugs, Biologics, and Medical Devices

Name: Development of FDA-Regulated Medical Products Prescription Drugs, Biologics, and Medical Devices
Price: 6.75 USD
Availability: InStock
ISBN: 9780873896139

ISBN-10: 0873896130

ISBN-13: 9780873896139

Edition: 2nd 2003

Authors: Elaine Whitmore

List price: $40.00

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Book details

List price: $40.00
Edition: 2nd
Copyright year: 2003
Publisher: ASQ Quality Press
Binding: Hardcover
Pages: 224
Size: 6.00" wide x 9.00" long x 0.75" tall
Weight: 1.100
Language: English



List of Figures and Tables


Foreword


Preface


Preface to Previous Edition


Abbreviations


Unique Challenges in Medical Product Development


Healthcare in the United States


It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation


Product Liability and Product Development


Bringing a New Medical Product to Market


Overview of the Approval Processes for Drugs, Biologics, and Medical Devices


Designing-in Quality


Designing-Out Disaster: Risk Analysis


Recalls, Revocations, and Withdrawals


Human Factors and the Nature of Relationships: Minimizing Medical Errors


Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials


How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care


Product Development Planning


Models and Metaphors: Product Development and the Product Development Organization


Components of Product Development Planning: The Product Development Process


Components of Product Development Planning: Development Portfolio Management


Components of Product Development Planning: Technology Assessment


Components of Product Development Planning: Technology Forecasting


More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality


Where Do We Go from Here?


Endnotes


Glossary


Resources


Index