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Improve your understanding of biotechnology's impact on drug development, production, and regulation with Managing Biotechnology in Drug Development. This informative book unravels the complex workings of the U.S. Food and Drug Administration's regulatory processes for drugs and biological products, including vaccines and recombinant DNA-derived products. It initially reviews the important role of biotechnology in medicine and the pharmaceutical industry. It then discusses the development of drugs and biologics from a regulatory perspective, spotlights biotechnology management strategies, and examines biotechnology product development by research institutes and the pharmaceutical industry. The book concludes with an insightful exploration of biotechnology's exciting future.