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HHS Restores Agency’s Premarket Review of LDTs

by | Dec 3, 2021

For over a year, makers of laboratory developed tests (LDTs) have been free of the yoke of US Food and Drug Administration (FDA) premarket review requirements. But on November, the Department of Health and Human Services (HHS) restored order by announcing that the agency will resume premarket review and emergency use authorization (EUA) of new […]

For over a year, makers of laboratory developed tests (LDTs) have been free of the yoke of US Food and Drug Administration (FDA) premarket review requirements. But on November, the Department of Health and Human Services (HHS) restored order by announcing that the agency will resume premarket review and emergency use authorization (EUA) of new […]

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