Development Of Fdaregulated Medical Products Prescription Drugs Biologics And Medical Devices Whitmore by Whitmore, Elaine 9780873896139, 9780873897105, 9781621980681, 0873896130, 0873897102, 1621980685 instant download after payment.

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 Administration’s Modernization Act (FDAMA), along with discussions on intellectual property, pharmacoeconomics, and technological and medical trends. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices industry. Helpful references include a glossary, acronyms, and a list of useful resources.
Content:
Front Matter
• List of Figures and Tables
Prefaces
• Abbreviations
• Table of Contents
•Part I. Unique Challenges in Medical Product Development• 1. Healthcare in the United States
2. It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation
3. Product Liability and Product Development
•Part II. Bringing a New Medical Product to Market 4. Overview of the Approval Processes for Drugs, Biologics, and Medical Devices
• 5. Designing-in Quality
6. Designing-out Disaster: Risk Analysis
7. Recalls, Revocations, and Withdrawals
• 8. Human Factors and the Nature of Relationships: Minimizing Medical Errors
9. Is it Safe and Does it Work?: Evaluating Safety and Efficacy in Clinical Trials
10. How Much is the Product Really Worth?: Outcomes Research, Pharmacoeconomics, and Managed Care
•Part III. Product Development Planning 11. Models and Metaphors: Product Development and the Product Development Organization
12. Components of Product Development Planning: The Product Development Process
13. Components of Product Development Planning: Development Portfolio Management
• 14. Components of Product Development Planning: Technology Assessment
• 15. Components of Product Development Planning: Technology Forecasting
16. More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality
17. Where Do We Go from Here?
• Endnotes
• Glossary
• Resources
Index