POLICY NEWS National Heart, Lung, and Blood Institute Funds Research to Improve Safety of Red Blood Cell Transfusions The National Heart, Lung, and Blood Institute, part of the National Institutes of Health, is funding nine research grants to determine if the safety and efficacy of red blood cell transfusions vary depending on how long the cells have been stored. [The National Heart, Lung, and Blood Institute, United States] New Videos Reveal How NIH Identifies the Most Promising Research Applications The National Institutes of Health’s (NIH) Center for Scientific Review released a new video to show new applicants and others how NIH assesses over 80,000 grant applications each year to help find those with the most merit. [National Institutes of Health, United States] FDA Told to Step Up Oversight of Offshore Clinical Trials The Food and Drug Administration (FDA) hasn’t done enough to monitor clinical trial data coming from overseas sites and patients, which increasingly dominate the studies used to support U.S. drug applications, according to a report from the Department of Health and Human Services’ inspector general. [Department of Health and Human Services, United States] FDA Pushes Orphan Drug Research The Food and Drug Administration (FDA) published a list of 235 treatments that may have benefit in rare disorders and already have marketing clearance for other uses. [Food and Drug Administration, United States] President of EFPIA Calls for a ‘New Dialogue’ on Medicines Andrew Witty, CEO of GlaxoSmithKline and President of European Federation of Pharmaceutical Industries and Associations (EFPIA), the body representing the research-based pharmaceutical industry in Europe, called for ‘a new dialogue’ between governments and the pharmaceutical industry in order to deliver patient access to better medicines and enhance Europe’s competitiveness as a base for R&D investment. [European Federation of Pharmaceutical Industries and Associations, European Union] Publication of New Enforcement Strategy A new enforcement strategy has been published by the Inspection, Enforcement and Standards Division. [Medicines and Healthcare Products Regulatory Agency, United Kingdom] FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests [Food and Drug Administration, United States] July 26-27, 2010: Meeting of the Blood Products Advisory Committee Announcement [Center for Biologics Evaluation and Research] Risk Evaluation and Mitigation Strategy Public Meeting [Center for Biologics Evaluation and Research, United States] National Human Genome Research Institute; Notice of Closed Meeting [National Institutes of Health, United States] Presentations About the Regulation of Blood and Tissues [Therapeutic Goods Administration, Australia]
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