Labs, Clinicians File Petition Challenging FDA’s Restrictions On PGx Tests

By Kelly Lienhard / January 16, 2020 at 11:11 AM
A group of laboratories and clinicians filed a citizen petition challenging FDA’s attempts to stop labs from providing physicians with genetic test data that assess a patient's risk of an adverse response or likelihood to respond to a given drug. FDA issued a safety communication in October 2018, followed up with a statement in November 2018 and then privately communicated with labs and issued a warning letter in 2019 saying the laboratory-developed pharmacogenomic test data should not be shared with...


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