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CDRH, LifeScience Alley Seek To Nationalize Reg Science Partnership

“What we’re trying to achieve is a structure that goes beyond one-off projects, but rather to support a variety of different projects on an on-going basis,” CDRH Director Jeffrey Shuren said.

CDRH and LifeScience Alley hope to establish by year’s end a long-term, national partnership structure for advancing regulatory science, which companies hope will help speed the path to market for devices.

FDA’s device center and the Minnesota-based trade group inked a memorandum of understanding, including local companies and the University of...

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