Biden WH Has Yet To Decide Whether To Restart FDA Regulation Of LDTs

By Kelly Lienhard / February 9, 2021 at 5:51 PM
The Biden White House has yet to decide whether to restore FDA’s regulation of laboratory-developed tests as it faces pressure from current and former FDA officials to revoke a controversial move by the Trump HHS to ax FDA’s oversight of the products. The current and former officials say FDA’s premarket review authority over LDTs must be restored to ensure Americans can trust COVID-19 that diagnostic testing is safe and accurate, especially as new mutations of the virus continue to exponentially...

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