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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 the rule’s requirements aren’t sustainable, and that the FDA won’t be able to handle the application volume

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