The Pharmaceutical Regulatory Process (Drugs and the Pharmaceutical Sciences)

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 Pharmaceutical Regulatory Process (Drugs and the Pharmaceutical Sciences) Author: Page Numbers Source ISBN: 1420070428 Publisher: CRC Press; 2 edition (December 2, 2008) Publication Date: December 2, 2008