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17 May 2013
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Capping off a week of several long-awaited guidance documents, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released yet another guidance document,
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17 May 2013
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When legislators passed a sprawling piece of legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA), they considered a huge range of problems facing both the US Food
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17 May 2013
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The medical device industry has long complained that the process of obtaining regulatory approval for its devices has become increasingly difficult over the course of the last decade. But in a
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16 May 2013
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The US Food and Drug Administration (FDA) has announced the approval of additional indications for Simponi (golimumab), a drug manufactured by Janssen Biotech intended to treat adults with moderate to
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16 May 2013
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Regulators with the US Food and Drug Administration (FDA) had a few things to clarify with industry and medical practitioners in the latest issue of the New England Journal of Medicine.Namely: No,
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16 May 2013
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A just-released update of the US Food and Drug Administration's Adverse Event Reporting System (FAERS) indicates that two drugs, metroprolol succinate extended release and serotonin-3 receptor
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16 May 2013
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The US Food and Drug Administration (FDA) has released two long-awaited guidance documents regarding the appeals process to be used by medical device manufacturers that have received a rejection by
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16 May 2013
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The US Food and Drug Administration (FDA) has proposed that ingestible medical devices be classified as Class II (moderate risk) medical devices subject to the 510(k) premarket notification process
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16 May 2013
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A new guidance document released by US federal regulators aims to establish best practices for conducting and reporting pharmacoepidemiologic safety studies that are conducted using electronic
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15 May 2013
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Regulators with the US Food and Drug Administration (FDA) announced on Tuesday the approval of Arbor Pharmaceuticals' drug Nymalize (nimodipine), a drug intended to treat brain hemorrhaging in
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