This Compendium includes a wealth of reports on drugs, biologics and medical
devices. The reports included consist of the authority to regulate drug
compounding; the law and intellectual property rights of biologics; federal
drug discovery and pricing; the FDA’s Safety and Innovation ACT (P.L. 112-114);
effects on pharmaceutical innovation and effects of generic brands;
infringement and experimental use under the Hatch-Waxman Act. Furthermore, the
reauthorization of the Prescription Drug User Fee Act (PDUFA); and how the FDA
approves drugs and regulates their safety and effectiveness.
Date of Report: January 17, 2013
Number of Pages: 294 Order Number: C12010 Price: $79.95
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