Ethics/Regulatory

KCR’s ethical assessment of clinical trials following EU CTR implementation

Thursday, March 30, 2017

Since the publication of the EU Clinical Trial Regulation (CTR) 536/2014 in the Official Journal, a new scheme of Clinical Trial Application (CTA) has been developed. Although certain rules for timelines, coordinated assessment and IT infrastructure are detailed, it remains up to each Member State how to organize ethical assessment and the cooperation of the Ethics Committee(s) (ECs) with National Competent Authorities (NCAs). KCR’s Anna Kubik, director Regulatory Affairs, who is a speaker at the DIA EuroMeeting this year, presented an overview of the current status focusing on the development of local requirements in terms of ethical assessment as well as proposed schemes respectively.

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Charles River Laboratories International to pay $1.8M to settle False Claims Act allegations

Friday, March 24, 2017

Charles River Laboratories International has agreed to pay the U.S. government $1.8 million to settle claims that it violated the False Claims Act by improperly charging for labor and other associated costs that were not actually provided on certain NIH contracts, the Justice Department announced. Charles River is a for-profit corporation headquartered in Wilmington, Massachusetts. 

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NIH achieves milestone to accelerate multisite clinical studies

Friday, March 24, 2017

Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

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Western IRB establishes single-IRB solution

Tuesday, March 21, 2017

Western Institutional Review Board (WIRB), a provider of ethical review of clinical research, announced the launch of its WIRB NIH Single Review Solution (SRS) for NIH-funded multi-site research. WIRB has an extensive background in reviewing clinical trials funded by NIH. Building upon status as the IRB of record for the majority of institutions that conduct clinical research in the U.S., WIRB NIH Single Review Solution will provide participating institutions the gold standard of research review.   

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FDA, EU drug inspectors ink Mutual Recognition Agreement

Monday, March 6, 2017

The U.S. and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

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