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14 January 2013
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The National Institutes of Health (NIH) has announced the launch of four new clinical trials, part of a long-running initiative that hopes to find new treatments for—and maybe even entirely
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Regulatory Update
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29 November 2012
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The European Commission has launched a consultation on the “situations” in which post-authorization studies would be imposed, something required by the 2010 legislation that revamped the EU
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25 October 2012
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The National Institutes of Health (NIH) is preparing to release a new report detailing the therapeutic needs of pediatric patients under the Best Pharmaceuticals for Children Act (BPCA), a piece of
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25 October 2012
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A new report released by the Senate Finance Committee slams medical device manufacturer Medtronic for allegedly ghostwriting studies used to support its Infuse Bone Graft system and paying hundreds of
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11 October 2012
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The National Institutes of Health (NIH) has announced a set of consensus recommendations it says will improve the way preclinical animal studies are designed and conducted, ultimately making them
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3 October 2012
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Two new reports released by the US Department of Health and Human Services’ (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with
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20 August 2012
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The US Food and Drug Administration (FDA) is preparing a workshop to focus on the design and appraisal of studies conducted after the approval of a product to obtain further evidence of its safety or
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30 May 2012
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The European Medicines Agency (EMA) is calling for a new guideline on multiplicity issues in clinical trials in a new concept paper released on 30 May.EMA first released a paper on multiplicity
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2 May 2012
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Months after the British Medical Journal (BMJ) reported that the US Food and Drug Administration’s (FDA) oversight of its clinical trials database was suffering from serious lapses in clinical trial
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24 April 2012
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The US Food and Drug Administration (FDA) moved on 23 April to notify pharmaceutical companies who had contracted out bioanlytical studies to contract research organization Cetero, which FDA has
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