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

ISBN-10: 0873896130
ISBN-13: 9780873896139
Edition: 2nd 2003
Authors: Elaine Whitmore
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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: 1.320
Language: English

List of Figures and Tables
Preface to Previous Edition
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
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