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BioWorld - Sunday, December 28, 2025
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Home » Final FDA user fee bill omits LDT regulation, accelerated drug approval program reforms
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Final FDA user fee bill omits LDT regulation, accelerated drug approval program reforms

Oct. 3, 2022
By Mark McCarty
The U.S. Congress has finally managed to pass legislation that reauthorizes several FDA user fee programs, but the final vote came on the last day of the federal fiscal year and addressed a stripped-down version of previous user fee bills. While several key considerations survived the shift to a lean bill, the FDA will have to wait for another day to be authorized to regulate lab-developed tests and to revise the accelerated approval program for pharmaceuticals, measures that may be revisited before the end of the current calendar year.
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