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HHS
New Twist: HHS Exerts Authority Over FDA on LDTs
CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…
CURRENT ISSUE
Volume XXVIII No. 3 – March 1, 2021
AN ONCOLOGY RESEARCH LAB demonstrates the usefulness of SARS-CoV-2 variant sequencing as hospitals, health systems, schools, and municipalities are interested in identifying infection sources and tracking the virus’ spread. Also, the conviction for manslaughter and mail fraud of a VA pathologist is a lesson for all anatomic pathology groups to heed, a lawyer explains.
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