Labs scramble after FDA loosens regulations on some tests

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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.

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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