Theorem Clinical Research

Ethics/Regulatory

EFPIA calls for universal adherence to European regulatory framework

Wednesday, June 11, 2014 12:51 PM

EFPIA, the European Federation of Pharmaceutical Industries and Associations, is concerned about a decision by the Italian health authority to allow the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. The organization calls on the European Commission to ensure member states adhere to the European regulatory framework and that financial considerations do not take precedence over regulatory decisions. 

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FDA launches openFDA to provide easier access to FDA public health datasets

Monday, June 2, 2014 01:19 PM

The FDA has launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

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EMA welcomes publication of the Clinical Trials Regulation

Friday, May 30, 2014 01:38 PM

The EMA welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (E.U.). This legislation will foster European competitiveness and innovative capacity, and facilitate swifter development of new medicines for patients. In addition to simplifying clinical trial approvals, the regulation foresees transparency on the conduct of trials in the European Economic Area, from the point of their authorization to the publication of the results of those clinical trials.

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WIRB-Copernicus Group launches oncology IRB to meet challenges of cancer research

Thursday, May 29, 2014 01:15 PM

By Ronald Rosenberg
CenterWatch Staff Writer

The WIRB-Copernicus Group (WCG), a large provider of regulatory and ethical review services for clinical research, has formed WCG Oncology, a new cancer-focused institutional review board, along with the WCG Oncology Expert Advisory Board, which includes James E. Rothman, Ph.D., the 2013 recipient of the Nobel Prize in Medicine and chairman of cell biology at Yale Medical School.  

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Ombudsman concerned by EMA policy change for clinical transparency

Wednesday, May 21, 2014 01:31 PM

In a letter to the EMA, the European Ombudsman, Emily O'Reilly, has expressed concern about a significant change of policy concerning clinical trial data transparency. The European Ombudsman investigates complaints about maladministration in the E.U. institutions and bodies.

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EMA, FDA release joint proposal for Gaucher research

Friday, May 16, 2014 12:49 PM

The EMA and the FDA have released a draft joint proposal to facilitate the clinical investigation of new medicines for the treatment of Gaucher disease in children. The document is released for public consultation until Aug. 31.

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FDA approves WuXi’s manufacture of ibalizumab in China for use under a U.S. IND

Wednesday, May 7, 2014 01:32 PM

The FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product, manufactured at WuXi PharmaTech's biologics facilities and developed by TaiMed Biologics for the treatment of HIV/AIDS infection. 

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FDA proposes expedited access program for devices that address unmet needs

Wednesday, April 23, 2014 02:17 PM

The FDA has proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.

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NHS England approves $13.5M in funding for hepatitis C drug

Thursday, April 17, 2014 11:16 AM

NHS England has approved a $13.5 million investment in Sofosbuvir for the treatment of hepatitis C. About 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Gilead Sciences’ new drug.

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Report: NHS financial crunch getting closer

Wednesday, April 16, 2014 01:23 PM

Financial confidence within the NHS is ebbing away, with a financial crisis looming in 2015-2016, according to the latest Quarterly Monitoring Report published by The King's Fund.

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September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

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Benefits outweigh the complexities, challenges of finding right vendors

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Lessons learned from medical device trials
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