Biotechnology and the Law
is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.
This book contains over 20 chapters by more than 20 leading experts in specialties such as patents, company formation, finance, federal regulation of research through funding, FDA regulation of biomedical research, approval of products for human use, privacy issues, litigation issues and more.