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The CenterWatch Weekly, August 14, 2017

Monday, August 14, 2017

The FDA passes new legislation for user fees and right-to-try applications

On August 3, the Senate quickly passed two new healthcare bills: user fee and right-to-try. The user fee bill is in line to be signed into law by President Trump. Once signed into law, the user fee legislation will reauthorize user fees for the FDA’s review of drugs and medical devices. Companies that produce these products will pay the FDA for these reviews. Those fees will then provide additional funding for the organizations’ therapy-related activities. The FDA utilizes user fees to fund more than a quarter of its annual budget, and the financing directly received from drug manufacturers are meant to help the FDA work toward approving life-saving therapies with a higher level of efficiency. 

New TrialScope platform aims to establish standard in global disclosure

Citing the need to meet requirements in 90 countries and across 30 trial registration websites, TrialScope has launched a “one entry” trial data disclosure platform. Its Core Disclosure solution is designed to allow research teams to approve disclosure once for worldwide dissemination. “Core Disclosure moves toward the ever-elusive “standard” for disclosing clinical trial data,” Thomas Wicks, chief strategy officer at TrialScope told CenterWatch. “This model greatly reduces the risk of data entry errors and inconsistent data becoming available to the public.”


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