‘Skinny’ User-Fee Reauthorization Would Leave Out Diagnostics Reform

A stripped-down version of the US FDA user-fee reauthorization package may be the best Congress can do before the August recess, but some say it won’t be enough. 

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A stripped-down version of the US Food and Drug Administration user-fee reauthorization package newly introduced in the Senate leaves out proposed diagnostics regulatory reform, marking yet another roadblock for the FDA’s ongoing efforts to bring regulation of more lab tests in-house.

Sen. Richard Burr, R-NC, introduced the FDA Simple Reauthorization Act on 14 July. Burr, the ranking member of the Senate Committee on Health, Labor and Pensions (HELP), had been highly critical of drug pricing proposals included in the FDA Safety and Landmark Advancements (FDASLA) Act as passed by the HELP Committee in June

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