How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
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Amazon Makes Bold Move into DTC Healthcare Services
Though the e-commerce giant recently closed its acquisition of One Medical, FTC antitrust intervention could disrupt Amazon’s plans.
FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is that current screening methods that rely on detecting high levels of
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FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary
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FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval
From - Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
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