Ethics/Regulatory

Sanford Heisler files $100m+ class action complaint against Daiichi Sankyo

Wednesday, February 13, 2013 10:32 AM

Six current and former female pharmaceutical sales professionals have filed a $100 million class and collective action gender discrimination lawsuit against Daiichi Sankyo, the U.S. branch of the Japan-based pharmaceutical company, in the U.S. District Court for the Northern District of California.

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WIRB Copernicus Group

Court shuts down U.S. operations of Titan Medical Enterprises

Monday, February 11, 2013 02:56 PM

A federal judge has ordered Titan Medical Enterprises, a Santa Fe Springs, Calif.-based manufacturer, and its owner, James L. McDaniel, to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

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FDA offers new guidance on developing drugs for Alzheimer's

Friday, February 8, 2013 11:47 AM

The FDA has issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable dementia.

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GVB BIO licenses biomarker database to FDA

Thursday, February 7, 2013 08:00 AM

GVK Biosciences, a discovery, research and development organization providing a broad spectrum of services, is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the FDA in its Biomarker Qualification Process.

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Almac’s new U.S. commercial packaging operations pass FDA inspection

Wednesday, February 6, 2013 09:16 AM

Global service provider Almac has passed FDA inspection of its new U.S. commercial packaging operations located in Audubon, Penn. The inspection took place on Jan. 9 and 10, 2013, from which the regulatory body concluded that the site is fully compliant with Good Manufacturing Practices, with no 483 issued.

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European Medicines Agency to focus on efficiency, transparency in 2013

Thursday, January 10, 2013 02:21 PM

The European Medicines Agency’s management board has adopted the agency’s work program and budget for 2013, with priorities continuing to be ensuring assessment activities are conducted to the highest scientific levels, increasing efficiency in its activities and developing initiatives for greater transparency and communication with stakeholders.

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NIHR launches new Clinical Trials Toolkit for researchers

Thursday, January 10, 2013 02:09 PM

The National Institute for Health Research (NIHR) has launched a new Clinical Trials (CT) Toolkit web site designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements.

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Mystery shopper campaign highlights NHS shortcomings in promoting clinical research

Thursday, January 10, 2013 02:05 PM

Many British NHS patients are hitting an information "brick wall" when it comes to finding out about clinical research, according to the results of a mystery shopper investigation commissioned by the National Institute for Health Research Clinical Research Network.

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FDA, new MDIC to develop regulatory science to speed access to medical devices

Monday, December 3, 2012 11:48 AM

The FDA has become part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment and review of new medical devices.

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EFPIA gives recommendations for clinical trial data transparency

Tuesday, November 27, 2012 02:43 PM

The European Federation of Pharmaceutical Industries and Associations recently held a workshop to give insight into the different views on the sensitive issue of clinical data transparency in Europe.

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