This Compendium includes a wealth of reports on drugs, biologics and medicaldevices. The reports included consist of the authority to regulate drugcompounding; the law and intellectual property rights of biologics; federaldrug 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, thereauthorization of the Prescription Drug User Fee Act (PDUFA); and how the FDAapproves drugs and regulates their safety and effectiveness.
Date of Report: October 17, 2012
Number of Pages: 268
Order Number: C-12010
Price: $79.95
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