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.
Updated 4-Feb-2013
Date of Report: February 4, 2013
Number of Pages: 313
Order Number: C12010
Price: $79.95
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