Special Update: US House of Representatives Passes 21st Century Cures Act

Posted by Cytel

Jul 10, 2015 12:54:00 PM

Here at Cytel, we are engaging in a small celebration this afternoon, as the US House of Representatives has just passed the FDA Reform Bill more generally known as the 21st Century Cures Act.

Although this bill is widely viewed as a reform bill, it will provide extensive funding to both the FDA and NIH to ensure that clinical and pharmaceutical research lives up to its potential to deliver...

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Topics: Bayesian Methods, Regulation, Medical Devices, Adaptive Clinical Trials


How Proposed Regulatory Reforms Will Affect Your Clinical Trial

Posted by Esha Senchaudhuri

Feb 17, 2015 6:40:00 PM

21st Century Cures (also called Cures2015) is a bipartisan initiative undertaken by the Committee on Energy and Commerce of the US House of Representatives. Amongst the many factors motivating this landmark legislation is the concern  that regulatory procedures must keep up to date with innovations in clinical development. Cures2015 aims to reform the regulation of drugs, biologics and medical...

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Topics: Bayesian Methods, Regulation, Medical Devices, Adaptive Clinical Trials


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