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FDA Cites Long-Term Precedent In Blocking Retail Genetic Screening Plans

This article was originally published in The Tan Sheet

Executive Summary

A particularly public pre-emptive stance by FDA's in vitro diagnostics oversight office halts Pathway Genomics' plans to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests

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Retailers CVS and Walmart, as well as the National Association of Chain Drug Stores, advocate for a central role for pharmacists in enabling a new class of nonprescription drugs. In comments to FDA, NACDS also supports a switch model that will protect the existing OTC class.

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