Latest News
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17 June 2013
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For years, regulators around the globe have been touting the challenges and benefits of globalization, explaining that a globally diverse product supply chain means needing to rely on regulatory
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Regulatory Update
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14 June 2013
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In draft guidance published today, the UK’s National Institute for Health and Care Excellence (NICE) recommends Alimera’s Iluvien for certain patients with chronic diabetic macular edema after the
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Regulatory Update
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13 June 2013
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The National Institute for Health and Care Excellence (NICE) yesterday issued final draft guidance recommending reimbursement for GlaxoSmithKline’s Revolade (eltrombopag) for chronic immune
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Regulatory Update
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7 June 2013
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The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance proposing to recommend aripiprazole (Abilify, Otsuka Pharmaceuticals Europe), for treating moderate to
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Regulatory Update
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7 June 2013
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four National Health Service hospitals have agreed to pilot a new tracking system for high risk medical devices.
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Regulatory Update
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6 June 2013
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A new report by Sweden’s Medical Products Agency and the National Board of Health and Welfare recommends that breast implants manufactured by now-defunct French manufacturer Poly Implant Prothèse
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Regulatory Update
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31 May 2013
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The UK’s cost containment agency, the National Institute for Health and Care Excellence (NICE), has issued a final appraisal determination reversing its January 2013 recommendation against the
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Latest News
Regulatory Update
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2 May 2013
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The UK’s cost containment agency, the National Institute for Health and Care Excellence (NICE), will soon begin to directly assist the National Health Service (NHS) with the use of innovative new
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Latest News
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18 April 2013
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UK regulators said Wednesday that they had, for the first time ever, gotten a man sentenced to prison for his role in falsifying pre-clinical data that was meant to support the regulatory approval of
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Latest News
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12 April 2013
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The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new set of lofty goals that it says will catapult the regulator to the top tier of those now on the "world
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