The Pharmaceutical Regulatory Process

by Ira R. Berry

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...

• Format: Hardcover
• Language: English
• ISBN: 1420070428
• ISBN13: 9781420070422
• Release Date: December 2008
• Publisher: CRC Press
• Length: 490 Pages
• Weight: 1.70 lbs.
• Dimensions: 1.2" x 6.1" x 9.1"