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User-Fee Facts: 10 Key Medtech Details From US FDA Agreements

 
• By David Filmore

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.

Businessman looking through a magnifying glass to documents

US FDA user-fee reauthorization legislation is proceeding through Congress, most recently with a May 11 markup in the Senate Health, Education, Labor and Pensions Committee, and lawmakers want a bill passed by July.

But it has already been almost nine months since FDA and industry trade groups completed negotiations on the underlying agreement that forms the basis of the reauthorization legislation. (Also see "Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations" - Medtech Insight, 23 August, 2016

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