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Expediting Drug Development

New FDA Breakthrough Therapy Designation Warmly Welcomed

By Peter Winter
Editor

Monday, September 23, 2013

It has been just over a year since the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. Contained within the act is a breakthrough therapy (BT) designation, intended to expedite the development and review of drug candidates, which has certainly found favor among biopharmaceutical companies.

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