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Senate Passes User Fee Reauthorization With FDA/Industry Proposals Intact

This article was originally published in The Gray Sheet

Executive Summary

Legislation reauthorizing the medical device user fee program passed the Senate May 9. Action is now needed in the House to prevent the program from expiring on September 30

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Congress Approves FDA Reform/User Fee Bill In The Nick Of Time

Congress gave final approval last week to a massive FDA bill that renews device and drug user fees for five years and strengthens product safety programs

Congress Approves FDA Reform/User Fee Bill In The Nick Of Time

Congress gave final approval last week to a massive FDA bill that renews device and drug user fees for five years and strengthens product safety programs

FDA User Fee Reauthorization Bill Cleared For House Floor Action

A medical device user fee reauthorization bill was approved June 21 by the House Energy and Commerce Committee and cleared for floor debate. The legislation largely mirrors proposals previously negotiated by industry and FDA, with some additional amendments addressing postmarket safety concerns (see chart: "1Selected User Fee Bill Amendments From House Energy and Commerce Committee:")

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