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PGx Testing Labs Concerned by FDA’s Statements, Actions

Federal agency is telling PGx testing labs to assess if their PGx lab tests comply with regulations

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) has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. …

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