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'We Should Have Acted Sooner' On DTC Gene Tests, Shuren Tells Lawmakers

This article was originally published in The Gray Sheet

Executive Summary

CDRH has been busy for the past two months in an effort to bring direct-to-consumer genetic test services into its regulatory fold, but Center Director Jeff Shuren acknowledged to a House subcommittee last week that the agency was slow to tackle the matter

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Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance

Companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications, according to the guidance. But, in response to public comments, FDA removed references that a company knowing or having “reason to know” that a lab is inappropriately using a test is grounds for enforcement.

Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance

Companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications, according to the guidance. But, in response to public comments, FDA removed references that a company knowing or having “reason to know” that a lab is inappropriately using a test is grounds for enforcement.

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Cook Group founder dies, son takes helm

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