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.
