Development of FDA-Regulated Medical B930

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B930 Development of FDA-Regulated Medical

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Products Prescription Drugs, Biologics, and Medical Devices Elaine Whitmore There have been many changes to the classification and regulation of prescription drugs, biologics and medical devices since the first 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 reviews the significant changes within the FDA that affect the development of medical products. It expands subjects that have become more critical such as clinical outcomes, human factors and marketing objectives, and addresses new topics such as the role of product development in hazard analysis, recalls and product liability. Ms. Whitmore is a product development and technology assessment consultant and has worked and written in the areas of management, product development, clinical outcomes, and regulatory affairs for more than 20 years. 202 pages, hardcover. B930

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