NOTE: There is a new edition of this book now available.
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.
"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
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