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) Ebook
Author:
File Size: 2549 KB
Print Length: 492 pages
Page Numbers Source ISBN: 1420070428
Publisher: CRC Press; 2 edition (December 2, 2008)
Publication Date: December 2, 2008
Language: English
