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US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate

Executive Summary

The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.

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Senate Approves FDA User Fee Reauthorization Bill On 94-1 Vote

The Senate Aug. 3 swiftly approved the FDA Reauthorization Act (FDARA) on a 94-1 vote. The president is expected to sign the bill, which previously passed the House and will enact the MDUFA IV user-fee agreement and make reforms tied to device accessory review, device facility inspections, and medical imaging FDA reviews.

Senate Expected To Vote On US FDA User-Fee Bill August 3

Senate Majority Leader Mitch McConnell, R-Kent., filed cloture on H.R. 2430, the FDA Reauthorization Act on device and drug user fees this week, and indicated debate and a vote on the bill will likely take place on Aug. 3.

Capitol Hill Update: Congress Gets Reprieve On User Fee Passage, While AdvaMed Weighs Device Tax Options

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