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Newsletter - April 21, 2022

On LDTs, FDA Punts it Back to Patients and Panders the Politicians 

This week FDA released a public warning about Lab Developed Tests (LDTs), specifically non-invasive prenatal screening (NIPS) tests, which puts the responsibility on the patients to verify the reliability of these tests while making statements that could be seen as pandering to the concerns of conservative politicians...Read More

Political Interference at FDA is Under-Reported: GAO

A Government Accountability Office (GAO) investigation found that FDA officials did not report potential political interference to influence their decisions due to lack of a formal process for the same or for fear of retaliation. The GAO recommended that FDA, CDC, and NIH should develop formal procedures for training personnel...Read More

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