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FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?

This article was originally published in The Gray Sheet

Executive Summary

It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do

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A particularly public preemptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans last week 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

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

A particularly public preemptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans last week 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

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

A particularly public pre-emptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans this week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move signals no changes to its enforcement policy for laboratory-developed tests.

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