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Development of Fda-Regulated Medical Products
* Taschenbuch: 202 Seiten
* Verlag: Amer Society for Quality; Auflage: 2 (Dezember 2003)
* Sprache: Englisch
* ISBN-10: 0873896130
* ISBN-13: 978-0873896139
* Größe und/oder Gewicht: 23,1 x 15,5 x 2 cm
There have been revolutionary changes to the classification and regulation of prescription drugs, biologics, and medical devices 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. The revised book includes: a review of the significant changes within the FDA that affect the requirements and review of medical products; 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. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices. Helpful references include a glossary, acronyms, and a list of useful resources.
After reading this book, individuals involved in medical product development, regardless of their background or functional discipline, will understand all facets of the process—from idea creation through to commercialization and marketing.
About the Author
Elaine Whitmore has worked and written in the areas of management, product development, clinical outcomes, and regulatory affairs for more than 20 years. Before becoming a product development and technology assessment consultant to companies in the healthcare products industry, she was director of product development for Johnson & Johnson Medical Inc. Whitmore earned her Ph.D. degree from Northwestern University.
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