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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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Massachusetts U.S. Rep. Ed Markey has announced the reintroduction of legislation that he says is intended to open up clinical trial data, introducing a measure of transparency and bringing the US
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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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The US Food and Drug Administration (FDA) may be at the forefront of trying to prevent the misuse and abuse of opioid painkillers, but as two Federal Register notices this week point out, it's not the
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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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