Table of Contents for Development of FDA-Regulated Medical Products : A Translational Approach


List of Figures and Tables
xi
Acronyms and Abbreviations xv
Preface xvii
Part I Unique Challenges in Medical Product Development
Chapter 1 Pushing the Pipeline: Translational Research and Product Development
3(16)
Productivity Gap
3(4)
Translational R&D
7(4)
Valley of Death
11(2)
Translational Research and FDA Initiatives
13(1)
Driving Biomedical Innovation
14(5)
Chapter 2 Healthcare in the United States
19(6)
Chapter 3 It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation
25(10)
Food and Drug Administration Modernization Act of 1997 (FDAMA)
25(2)
Prescription Drug User Fees
27(1)
Information on Off-Label Use and Economics
28(1)
Risk-Based Regulation of Medical Devices
28(1)
Standards for Medical Products
29(1)
The New FDA
29(6)
Chapter 4 Classifying Medical Products
35(18)
Drugs and Biologics
36(1)
Drugs
37(1)
Biologics
38(3)
FDA Consolidation of Drugs and Biologics
41(2)
Medical Devices
43(3)
Combination Products
46(7)
Chapter 5 Product Liability and Product Development
53(10)
Preemption
54(1)
Medical Devices
54(1)
Drugs
55(1)
Basis of Product Liability
56(1)
Design Defects
56(1)
Warning Defects
57(1)
Manufacturing Defects
57(1)
The Role of Product Development Planning
57(6)
Part II Bringing a New Medical Product to Market
Chapter 6 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices
63(14)
Drugs
64(1)
Screening
64(1)
Preclinical Testing
64(1)
Investigational New Drug Application
65(1)
Clinical Trials
65(1)
New Drug Application
66(1)
Inspections
66(1)
Generic Drugs and Abbreviated New Drug Applications
67(1)
Biologics
68(1)
Biosimilar Products (Follow-On Biologics)
68(1)
Medical Devices
69(2)
General Controls
71(1)
Special Controls
72(1)
Premarket Notification
73(2)
Premarket Approval
75(2)
Chapter 7 Quality by Design
77(10)
Design Controls
78(3)
Design and Development Planning
81(2)
Design Input
83(1)
Design Output
83(1)
Design Review
84(1)
Design Verification and Validation
84(1)
Design Transfer
85(1)
Design Changes
85(1)
Design History File (DHF)
85(1)
Other Considerations in Design Controls
85(2)
Chapter 8 Designing-Out Disaster: Risk Analysis
87(8)
Quality Risk Management
90(1)
Risk Analysis Techniques
91(4)
Chapter 9 Recalls, Withdrawals, and Revocations
95(8)
Recalls
95(1)
Firm-Initiated Recalls
96(1)
FDA-Requested Recalls
96(1)
FDA-Ordered Recalls
96(1)
Withdrawals
97(1)
Revocations
97(3)
Influence of Product Development Planning
100(3)
Chapter 10 Human Factors and Usability Engineering: Minimizing Medical Errors
103(12)
Chapter 11 Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials
115(14)
Preclinical Testing
116(4)
Clinical Trials
120(2)
Drugs and Biologics
122(1)
Endpoints and Biomarkers
123(1)
Medical Devices
124(3)
Diversity in Clinical Trials
127(2)
Chapter 12 How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care
129(10)
Clinical Outcomes
131(1)
Pharmacoeconomics and Economic Outcomes
131(1)
Quality-of-Life Outcomes
131(2)
Comparative Effectiveness Research
133(1)
Outcomes and Product Development Planning
134(5)
Part III Product Development Planning
Chapter 13 Models and Metaphors: Product Development and the Product Development Organization
139(10)
Swimming Against the Stream
140(1)
The Cross-Functional Organization
141(8)
Chapter 14 Components of Product Development
Planning: The Product Development Process
149(3)
Stage 1 Discovery
152(4)
Stage 2 Feasibility
156(2)
Stage 3 Optimization
158(1)
Stage 4 Demonstration
159(1)
Stage 5 Production
159(1)
Stage 6 Launch and Follow-Through
160(1)
Chapter 15 Components of Product Development Planning: Development Portfoliio Management
161(14)
Killing a Project
172(3)
Chapter 16 Components of Product Development Planning: Technology Assessment
175(8)
Chapter 17 Components of Product Development Planning: Technology Forecasting
183(10)
Chapter 18 Better Double-Check That: A Guide for the Risk-Averse
193(14)
Planning for Promotional Opportunities
193(2)
Speed to Market versus Product Promotional Preferences
195(1)
Intellectual Property
195(3)
Don't Forget the Budget
198(1)
Conflict Resolution: What About Game Theory?
199(1)
Decision-Making Games
200(1)
Global Games
201(1)
Product Development Ecosystem Games
201(1)
Quality Challenges
202(5)
Chapter 19 Where Do We Go From Here?
207(4)
In Closing
208(3)
Appendix: Resources 211(8)
Endnotes 219(6)
Glossary 225(6)
Index 231