Small Labs Push Back Against VALID Ahead Of User Fee Markup

Smaller laboratories are urging lawmakers to scrap provisions in the Senate’s user fee reauthorization package that would give FDA premarket authority over laboratory-developed tests, ahead of the Senate health committee’s planned markup of the user fee bill Tuesday (June 14). According to the labs, additional premarket requirements for LDTs would put financial and time constraints on certain labs, which could hamper future development of tests for rare diseases and diminish the next generation of laboratory workers. The Senate’s draft...