Latest News
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17 May 2013
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The European Medicines Agency (EMA) has announced its adoption of the International Conference on Harmonisation's (ICH) M7 guideline on controlling carcinogenic risk in pharmaceutical products when
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Regulatory Update
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17 May 2013
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The European Commission’s three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its
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Latest News
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15 May 2013
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French regulator ANSM has announced yet another problem—the second in as many weeks following a major scandal in 2012—this time with the Jarvik 2000 heart device due to violations of French laws and
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Latest News
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9 May 2013
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The European Medicines Agency (EMA) has announced that it will, starting immediately, be instituting new changes meant to simplify the process by which fees for orphan medicine applications are paid
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Latest News
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24 April 2013
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The European Medicines Agency (EMA) has announced the release of a new concept paper regarding the extrapolation of an experimental drug product's safety and efficacy data to other subgroups,
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Latest News
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17 April 2013
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A new draft legislative report issued by a member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), Peter Liese, would make significant changes to the
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Latest News
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15 April 2013
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A key member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) today issued a draft report that calls for the establishment of a regulatory system that
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Latest News
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10 April 2013
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The European Commission (EC) has announced the release of its recommendation on a framework for a unique device identification (UDI) system for medical devices marketed in the EU, bringing the country
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Latest News
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9 April 2013
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A new "comprehensive analysis" conducted by the European Medicines Agency (EMA) has found that more than 60% of patients enrolled in pivotal trials submitted in support of drug applications—that is,
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Latest News
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4 April 2013
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EU regulators are preparing a new guideline to assist companies in the development of treatments for Autism Spectrum Disorder (ASD), a collective term referring to the wide range of disorders that
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