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White House Continues To Push For Higher User Fees From Industry

The White House expressed general support for the US House-passed user fee reauthorization bill while also demanding user fees be increased, creating some confusion in industry.

While the current bill reauthorizing US FDA user fees seems to be a done deal in Congress, the Trump White House continues to insist medical products industries pick up the entire tab for reviewing drugs, biosimilars and devices.

On July 12, the House passed the FDA Reauthorization Act or FDARA, which includes user fee authorizations for drugs, biosimilars and medical devices as well as several riders addressing medical device accessories, device facility inspections and other issues. The bill is now on its way to the Senate for approval and has strong bipartisan support, as well as support from industries and FDA

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