News

Latest News | 14 January 2013

NIH Announces Support for Alzheimer's Clinical Trial, Regulatory Science Initiative

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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 Read More...

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Latest News Regulatory Update | 29 November 2012

Reimbursement Hurdles Focus of EU Consultation on Post-Authorization Studies

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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 Read More...

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Latest News | 25 October 2012

NIH to Publish Updated List of Priority Therapeutic Areas for Pediatric Research

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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 Read More...

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Latest News | 25 October 2012

Senate Investigation Claims Medtronic Edited, Influenced Studies

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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 Read More...

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Latest News | 11 October 2012

NIH Initiative Hopes to Improve How Preclinical Testing is Reported

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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 Read More...

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Latest News | 3 October 2012

Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

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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 Read More...

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Latest News | 20 August 2012

FDA Wants Post-Approval Studies to Address Broader Public Health Needs

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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 Read More...

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Latest News | 30 May 2012

EMA Proposes Changes to Existing Clinical Trial Guideline on Multiplicity Issues

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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 Read More...

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Latest News | 2 May 2012

FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors

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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 Read More...

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Latest News | 24 April 2012

FDA: Companies Who Dealt With Cetero Must Repeat or Confirm Some Bioanalytical Studies

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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 Read More...

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