Commercializing Successful Biomedical Technologies: Basic Principles in the Development of Drugs, Diagnostics, and Devices (S.S. Mehta; 2008) [Book Review]

Abstract

This textbook is a nicely laid out logical road map to the development of drugs, devices, and diagnostics in the United States. Some of the topics covered include: an overview of the industry; market research; intellectual property law as practiced in the United States; new product development; an overview of Title 21 Code of Federal Regulations and the Food and Drug Administration operations; manufacturing; marketing and sales; and product liability. Each chapter begins with a bullet listing of the learning points involved in the chapter. Each chapter concludes with an overall summary, exercises as appropriate, a reference listing, and appendices as necessary. The book is a well-written introduction to the field of drug and device development and commercialization in the United States.