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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.

[Editor's note:This story was updated on Aug. 24 to reflect that the proposed revenue from MDUFA IV fees is a significant increase compared to MDUFA III.]

US FDA has struck a deal with industry groups in the latest round of negotiations over the Medical Device User Fee Act. The fourth iteration of the user fee framework...

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