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2 August 2012
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A new study published in the New England Journal of Medicine (NEJM) assessing the performance of US and EU regulatory and reimbursement authorities finds the US actually exceeds several of its EU
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2 August 2012
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The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final
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2 August 2012
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The US Food and Drug Administration (FDA) has announced a four-day meeting to discuss clinical endpoints potentially capable of being used to support future drug development in four therapeutic
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2 August 2012
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A new bill proposed in the US House of Representatives would provide relief to small companies and other entities found to be violating paperwork-based regulations for the first time.The bill, the
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Regulatory Update
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2 August 2012
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The European Medicines Agency (EMA) is phasing out so-called "follow-up measures" for human drugs requiring post-marketing studies this month, instead replacing them with three categories of
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1 August 2012
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The European Medicines Agency (EMA) has released a new reflection paper on the risks of adverse immune system reactions in hemophilia patients treated with Factor VIII products and how these factors
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1 August 2012
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There’s a new top threat to the safety of the nation’s blood supply. The Wall Street Journal reports donated blood products containing bacterially contaminated blood platelets have usurped HIV for the
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1 August 2012
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Under a new piece of bipartisan legislation introduced in the Senate, all federal agencies, including the US Food and Drug Administration (FDA), would be subject to new standards intended establish
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1 August 2012
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The US Food and Drug Administration (FDA) has issued a final rule regarding electronic device registration and listing requirements, putting into practice a long-awaited rule combining the
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1 August 2012
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How do the US and EU regulatory systems for medical devices match up in a head-to-head comparison? A new systematic review published in the journal Public Library of Science: Medicine (PLoS:M) says
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