The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics. At its heart, the 528-page final rule (PDF) looks ...
New findings from the RECOVER-Adult cohort study show that 25 routine clinical lab tests are not effective in diagnosing postacute sequelae of SARS-CoV-2 infection, echoing results from earlier ...
WASHINGTON (AP) — The Food and Drug Administration on Friday laid out a proposal to begin regulating laboratory medical tests, a multibillion-dollar industry that the agency says poses a growing risk ...
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