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Experts Say FDA Isn’t Ready For LDT Application Deluge

 
• By Hannah Daniel

Former FDA officials and Congressional staffers speaking at a FDLI panel say that the FDA isn’t prepared for the number of applications that will arise from the new proposed LDT rules.

• Source: Shutterstock

The US Food and Drug Administration is unprepared for the wave of applications it will receive as a part of its proposed rule to better regulate laboratory-developed tests (LDT).

A panel of stakeholders, including former Congressional staffers and FDA officials, discussed the controversial rule proposed rule at the Food and Drug Law Institute’s 2023 Enforcement Summit. They say that...

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