pgx testing labs

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PGx Testing Labs Concerned by FDA’s Statements, Actions

By Mary Van Doren, from the Volume XXVI No. 12 – September 3, 2019 issue

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. In

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PGx Labs Concerned by FDA’s Statements, Actions

By Joseph Burns, from the Volume XXVI No. 12 – September 3, 2019 issue

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 certain medications. Some pathologists and lab executives have criticized the FDA’s actions

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Tag: pgx testing labs

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