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The Pharmaceutical Regulatory Process
Hardcover
Series: Drugs and the Pharmaceutical Sciences, Book 185
ISBN13: 9781420070422
Publisher: CRC Press
Published: Dec 2 2008
Pages: 490
Weight: 1.70
Height: 1.20 Width: 6.10 Depth: 9.10
Language: English
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 compliance
- pharmacovigilance programs designed to prevent widespread safety issues
- legal issues surrounding the sourcing of foreign APIs
- the issues of counterfeit drugs
- updates on quality standards
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