Regenerative Medicine Group Says Cures Act Will Help Industry
The 21st Century Cures Act will require US FDA to create standards and an expedited approval process for regenerative medicine products. Trade group ARM supports the efforts.
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The agency plans to offer a series of guidance documents on regenerative product development as enforcement against "unscrupulous actors" continues.
Dozens of reforms impacting the medtech sector were signed into law Dec. 13 as part of the 21st Century Cures Act. Here's a breakdown of the provisions most important to device- and diagnostic-makers.
The US Food and Drug Administration and the Veterans Health Administration are partnering to create tools that can help novel technology reach patients more quickly and easily.