Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations
FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.
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The National Evaluation System for health Technology, which FDA officials have said will re-make device data collection in the US, is finally getting off the ground. Rachael Fleurence took the helm last month as the executive director for the NEST Coordinating Center. In a podcast interview with Medtech Insight, Fleurence talks about her qualifications, and what she hopes the project will accomplish within the next year, and beyond.
While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.
President Trump's initial budget plan for US FDA would, it appears, make industry-paid user fees a much larger proportion of the agency's budget, but details are lacking. As is, the plan could complicate agreements that came out of FDA-industry user-fee negotiations last summer, but observers say this is just the first step in a process and Congress will ultimately decide. Trump would also shave 22% from the National Institutes of Health.