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  • New Combination Vaccine Approved by FDA

    A new combination vaccine that protects infants against meningococcal disease and Hib disease received approval from the US Food and Drug Administration (FDA) on 14 June, the agency said. Reuters reports the vaccine, GlaxoSmithKline Biologicals'Menhibrix, had twice been rejected by the agency in both 2010 and 2011 after regulators raised questions about the benefit:risk profile of the product. The questions seemed to be resolved-or at least mitigated-during the product...
  • CBER Releases Strategic Plan for 2012-2016 Period

    The US Food and Drug Administration's (FDA) biologics regulatory body, the Center for Biologics Research and Evaluation, has released its strategic regulatory plan for the upcoming five years. The plan, " Strategic Plan for Regulatory Science and Research ," was released 10 May 2012 and explores how the center plans to "provide the environment to facilitate the development of new biological products and evaluate them for safety and effectiveness." CBER's plan outlines s...