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First salvo fired against FDA’s laboratory developed test rule

In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and Drug Administration (FDA), claiming the...more

FDA updates FAQ on COVID-19 tests and validation

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and...more

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