Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics and Medical Devices
Elaine Whitmore
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.
| FROM THE FOREWORD TO Development of FDA-Regulated Medical Products "As a business leader in the pharmaceutical industry whose career has been intimately tied to the product development process, I find Development of FDA-Regulated Medical Products to be comprehensive, inclusive and well organized."
- Carrie S. Cox, President, Global Pharmaceuticals
Schering-Plough |
Preview a sample chapter from this book along with the full table of contents by clicking here.
You will need Adobe Acrobat to view this pdf file.
224 pages.
ISBN 978-0-87389-613-9.
6 x 9.
Hardcover.
2004
Item: H1198
Member Price: $33.00
List/Forum-Division Price: $55.00
Related Products:
Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics and Medical Devices
Elaine Whitmore
Requests for multiple subscriptions should be directed to ASQ Customer Care at 800-248-1946 or 414-272-8575.
|
