Medical eBooks | Basic Medical Sciences

FDA Regulatory Affairs

by Douglas J. Pisano

2020-07-24 02:27:49

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Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval proce... Read more
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in Less

Book Details

Publication date August 11, 2008
Languageeng
ISBN9781420073553
autor-image
Douglas J. Pisano
Author
DOUGLAS J. PISANO is Dean of the School of Pharmacy and Professor of Pharmacy Administration, Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts, USA. Dr. Pisano received his...

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