Bringing Your Pharmaceutical Drug to Market
Edited by Hall, Hill, and DiSpirito
Softcover | 800 pages
Print ISBN | 978-1-935065-75-3
Written by the most experienced drug attorneys in the United States and edited by three distinguished authorities in the field, Bringing Your Pharmaceutical Drug to Market is one of the most comprehensive guidebooks ever published about the lifecycle of pharmaceutical drug development and marketing.
This unique 36-chapter treatise fills a gaping hole in the world of pharmaceutical reference materials, a world where only one in 5,000 drugs that make it to the preclinical testing phase is approved and the cost of creating a new drug is $5 billion. It explores the Food and Drug Administration’s vast and complex regulatory systems and standards with regards to pharmaceutical development and more – from protecting your intellectual property and establishing your business, to research and development, to FDA approval and post-marketing requirements. This book includes valuable information on FDA’s administrative and enforcement authority as well as the agency’s role in ensuring drug safety and efficacy. This resource contains the latest need-to-know information on new statutes, regulations, enforcement actions, and caselaw.