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pgx testing labs
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
CURRENT ISSUE
Volume XXIX, No. 8 – June 6, 2022
More changes are coming for the clinical lab industry, including the Department of Justice’s move to hold individuals accountable for lab fraud, even after company settlements have been reached. Also, integrated delivery networks are forming new mergers to create ever-larger business entities, all of which has implications for labs.
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