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Monday, August 31, 2020

Labs scramble after FDA loses regulations on some tests

August 31, 2020 Modernhealthcare-Health News , 0 Comments

HHS' decision to abruptly restrict the Food and Drug Administration's ability to require premarket review of laboratory-developed tests (LDTs) through guidance and other informal communications has industry players scrambling to figure out how this impacts their diagnostic regulatory strategies.



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