'Cures' Innovation Fund Targeted At Some Device Provisions In Latest Bill
This article was originally published in The Gray Sheet
FDA officials could draw from $550 million of a new “Innovation Fund” to implement certain 21st Century Cures legislation device reforms, including a breakthrough device program, health IT reforms and other provisions. The latest version of the bill, which newly directs those funds to device sections, is heading to the House floor this week.
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The 21st Century Cures bill passed on a 344-77 vote, attracting significant bipartisan support in the House. It includes multiple provisions supported by the device industry, including a priority review pathway for breakthrough devices. Attention now moves to the Senate, which is working on its own bill that could face budget barriers and calls for more safety protections.
Margaret Hamburg’s departure from commissioner post seems to be proceeding smoothly; proposals in the House 21st Century Cures discussion draft would mandate a similar process always be followed.
The diagnostics company has secured $10m from the foundation to develop a biomarker test for Parkinson’s disease.