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…
