A Final LDT Rule in April!? Will FDA be prepared?
FDA Law
DECEMBER 11, 2023
Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It
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