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9 November 2012
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The US Food and Drug Administration (FDA) has released a long-awaited final guidance for industry regarding the development of artificial pancreas device systems (APDS), part of a broader effort it
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Regulatory Update
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25 October 2012
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The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has issued a draft guidance recommending the use of Novartis' Tobi Podhaler, an inhaled tobramycin
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23 October 2012
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A new guidance for industry published by the US Food and Drug Administration (FDA) includes information about new registration requirements established under the Food Safety Modernization Act (FSMA),
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Regulatory Update
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22 October 2012
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France’s cost containment agency, the National Authority for Health (HAS), recently released guidance on the methods that it uses when it conducts “economic evaluations” of medicines and medical
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Regulatory Update
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22 October 2012
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The UK’s cost containment agency, the National Institute for health and Clinical Excellence (NICE), has published supporting evidence for the off-label use of Pfizer’s Cyklokapron by the National
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17 October 2012
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The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released two new guidance documents pertaining to how the agency plans to calculate review time and
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16 October 2012
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The US Food and Drug Administration (FDA) has released a new draft guidance document on a new digital medical device submission system.The system, known as the eCopy Program, is soon to be required of
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Regulatory Update
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12 October 2012
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UK’s cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has published guidance on the management of Crohn´s disease with both new and established drugs
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9 October 2012
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The European Medicines Agency (EMA) is out with a new guideline on conducting clinical trials for products intended to treat schizophrenia which it says addresses a number of specific issues,
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8 October 2012
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Several prominent members of the medical device industry, including its largest trade group, have voiced their concerns about a new guidance document released by the US Food and Drug Administration
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