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US user fee bill advances in Senate; House session postponed

This article was originally published in SRA

Executive Summary

While US lawmakers spent a good deal of time praising each other for their bipartisanship during a 25 April Senate mark-up session for the legislation intended to reauthorise the Food and Drug Administration's authority to collect user fees from drug and device makers – plus take in new fees from generics and biosimilars manufacturers – measures about holding companies accountable for fraud violations and permitting pharmaceutical imports from Canada dominated much of the hearing1,2.

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