 | GetTextbooks.co.uk Compare Price & Save up to 90% | | |
|
George Washington University - FALL 2012 | ||
Section DE | ||
 | FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (2nd Edition) by Douglas J. Pisano (Editor), David S. Mantus (Editor) Hardcover, 464 Pages, Published 2008 ISBN-10: 1-4200-7354-0 / 1420073540 ISBN-13: 978-1-4200-7354-6 / 9781420073546 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 co | |