Good Manufacturing Practices (3rd Edition)

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Good Manufacturing Practices (3rd Edition)
Drug and Market Development Publishing
July 1, 2006
423 Pages
Pub ID: DSMD1317950
US $795.00 Hard Copy Mail Delivery

Abstract
D&MD's updated Good Manufacturing Practices professional development guide provides pharmaceutical and biological companies of all sizes with assistance in regulatory compliance. The guide examines the new FDA Guidance for Industry documents and a new amendment covering an exemption for investigational drugs in Phase 1 studies. The guide is addressed particularly to smaller sized companies, perhaps those with their first new drug, working on this extra challenge to their capabilities.