Posted on December 8, 2016

21st Century Cures – An Opportunity for Real World Evidence

A bill soon to be passed into law brings real world evidence into health care decision making

On Wednesday, December 7, the U.S. Senate passed a new version of the 21st Century Cures Act. The bipartisan bill contains a number of provisions to get innovations to patients as quickly and safely as possible, and expected to be quickly signed into law by President Obama.

The bill has a number of measures that address the development and approval of new therapies, including the evaluation of the use of real world evidence (RWE) in drug approval. The bill requires that the FDA evaluate the use of RWE to help support the approval of a new indication for previously approved drug and for post-approval study requirements.

NEHI’s work has shown that RWE can hold great value for understanding new innovations and that RWE should become a part of health care decision making.


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