ParagonRx® | Minimize Risk and Optimize Use

This year, Congress will have to reauthorize the Prescription Drug User Fee Act (PDUFA), which funds the Food and Drug Administration’s (FDA) drug approval process. As noted by Amanda Kronquist, a Heritage Health Policy Graduate Fellow, the FDA drug approval process has become “increasingly unpredictable, uncertain, and inefficient.”...

The European Medicines Agency, together with the European Union member states and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Over the next five months, the Agency says it will finalize its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for July 19, 2012...

inVentiv Medical Management, an inVentiv Health company and leading provider of physician-directed, nurse-supported and technology-enabled medical management solutions, announced today the national launch of a series of new solutions that help to prevent the inappropriate and ineffective care often associated with some of the most complex and costly health conditions...

The medical marijuana drug Sativex, which could be approved in the United States in the coming years as a treatment for pain relief, has little potential for abuse, experts say...

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Centre for Innovation in Regulatory Science, Ltd. (CIRS) have announced that PhRMA has transferred its Benefit-Risk Action Team (BRAT) framework to CIRS in order to further the program’s technical development and broaden input from the scientific community...