FDA Week - 05/19/2017

House E&C health subcommittee rejects Price request to reopen user fees . . .

FDA User Fee Package Advances To Full E&C Committee By Voice Vote

May 18, 2017
A House subcommittee easily passed FDA user fee legislation Thursday (May 18) with riders allowing over-the-counter hearings aids, requiring risk-based device inspections, offering new exclusivity for a new class of competitive generic drugs and restricting drug imports, and in the process brushed off the Trump administration's call for a doubling of the user fee levels FDA negotiated with industry. The vote moves the Food and Drug Administration Reauthorization Act of 2017 (FDARA) to the full Energy & Commerce Committee. E&C...

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