Ethics/Regulatory

EMA to publish and enable access to clinical trial data

Friday, August 17, 2012 09:27 AM

The European Medicines Agency (EMA) will proactively publish clinical trial data and enable access to full data sets by interested parties.

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WIRB Copernicus Group

FDA solicits industry input about open, consensus-based standards

Friday, August 17, 2012 09:19 AM

The FDA is announcing a meeting “Regulatory New Drug Review: Solutions for Study Data Exchange Standards,” on Nov. 5, to solicit input from industry, technology vendors and the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. The FDA also is seeking input from stakeholders on pre-meeting questions discussed below. Registration is required in advance and will be limited.

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CRF Health eCOA webinar series

Codeine in certain children may lead to rare, but life-threatening AEs or death

Wednesday, August 15, 2012 01:48 PM

The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy or adenoidectomy for obstructive sleep apnea syndrome.

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Sen Gillibrand announces bill to spur growth of science and technology jobs

Friday, August 10, 2012 02:58 PM

Sen. Kirsten Gillibrand (D-N.Y.) announced legislation to spur the growth of new science and technology jobs in Western New York and across New York. The “America Innovates Act” would help scientists and researchers secure valuable resources and training to turn their discoveries into marketable products, new high-tech companies and jobs.

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Markey, House democrats introduce bill to protect human subjects in clinical trials

Monday, August 6, 2012 11:59 AM

Rep. Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, has introduced H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act of 2012 to close clinical trial loopholes and bring certainty and transparency to life-saving research studies.

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EFPIA supports E.C. adoption of clinical trials regulation

Monday, July 23, 2012 01:01 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA), a group of 33 European national pharmaceutical industry associations and 35 companies, welcomes the proposal for a new regulation on clinical trials on medicinal products for human use adopted July 23 by the European Commission as a first step towards further cooperation in the clinical trials assessment process across the E.U.

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FDA introduces new safety measures for opioid medications

Monday, July 9, 2012 04:36 PM

The FDA has approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

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FDA proposes unique device identification system for medical devices

Thursday, July 5, 2012 12:11 PM

In response to requirements in legislation that passed Congress with broad bipartisan support, the FDA has proposed that most medical devices distributed in the U.S. carry a unique device identifier, or UDI.

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Schulman Associates IRB offers oncology-focused review board

Wednesday, June 27, 2012 03:46 PM

In response to the recent increases in oncology research conducted in North America, Schulman Associates IRB will offer a weekly board meeting of the new Schulman Oncology Board, dedicated to the review of oncology research, beginning July 23.

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EMA boosts transparency with online publication of suspected side effects

Friday, June 1, 2012 11:28 AM

The European Medicines Agency has begun publishing suspected side effect reports for medicines authorized in the European Economic Area (EEA) on a new public website: www.adrreports.eu.

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