FDA set to unveil new rule on Laboratory Developed Tests this August

Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

Quick Background: The Unified Agenda

The Unified Agenda is updated twice per year. The editions are titled the “Spring” and “Fall” Unified Agendas, but their actual publication timelines rarely align with their actual publication.

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