The Pharmaceutical Regulatory Process Hardback
Edited by Ira R. Berry, Robert P. Martin
Part of the Drugs and the Pharmaceutical Sciences series
Hardback
- Information
Description
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices.
It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices.
Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliancepharmacovigilance programs designed to prevent widespread safety issueslegal issues surrounding the sourcing of foreign APIsthe issues of counterfeit drugsupdates on quality standards
Information
-
Out of StockMore expected soonContact us for further information
- Format:Hardback
- Pages:490 pages, 35 Illustrations, black and white
- Publisher:Taylor & Francis Inc
- Publication Date:02/12/2008
- Category:
- ISBN:9781420070422
£180.00
£143.67
Information
-
Out of StockMore expected soonContact us for further information
- Format:Hardback
- Pages:490 pages, 35 Illustrations, black and white
- Publisher:Taylor & Francis Inc
- Publication Date:02/12/2008
- Category:
- ISBN:9781420070422
