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    New Report Looks at Challenges to Availability of Blood, Plasma in EU

    A new report from Creative Ceutical examines the availability of blood products in the EU and addresses some of the regulatory challenges impacting their supply. The report, An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients , was commissioned by the European Commission’s Executive Agency for Health and Consumers (EAHC), and features commentary by stakeholders from various industry groups, pati...
  • US Blood Donation Process to Become Easier for Recent Travelers to Cancun, Cozumel

    Malaria-a mosquito-borne disease common in some developing countries that kills hundreds of thousands of people each year-is a serious threat to the health of even healthy humans. But as a new guidance document released on 19 August 2013 by the US Food and Drug Administration (FDA) notes, the disease isn't just confined to the developing world. There is a risk, albeit a small one, of malaria being transmitted during blood transfusions-a risk FDA believes is no longer refl...
  • FDA Preparing to Release Guidance on Leukocyte-Based Transfusion Products

    The US Food and Drug Administration (FDA) is preparing to release a new guidance for industry regarding transfusion products containing leukocyte reductions. In a pre-release notice of impending availability on 24 September, FDA said the guidance, Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion , provides recommendations for validation and quality control monitoring. In addition, the guidance is also intended to be use...