FDA Regulatory Affairs
by Douglas J. Pisano 2020-07-23 22:57:49
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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
  • Publication date
  • Language
  • ISBN
  • August 11, 2008
  • eng
  • 9781420073553
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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