Senate Panel Rebuffs Bid To Weaken LDT Measures In User Fee Bill

By Kelly Lienhard / June 16, 2022 at 1:48 PM
The Senate health committee stood firm on its user fee provision that gives FDA authority to review and regulate laboratory-developed tests, tabling an amendment that would have weakened the language by exempting academic and hospital labs from the premarket review requirements. The amendment, which was offered during the committee’s markup of the broader user fee package this week, potentially could still come up on the Senate floor or when the upper chamber merges its user fee legislation with the House...

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