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Laboratory Developed Tests OIRA Medical Devices

Venable LLP

The End of FDA’s LDT Rule, Trump Administration’s Regulatory Agenda Released, an Analysis of HHS Workforce Reductions Raises...

Venable LLP on

Earlier this month, the Office of Information and Regulatory Affairs (OIRA) updated its list of rules pending review under Executive Order 12866 to include FDA's request to rescind its controversial Laboratory Develop Test...more

Goodwin

FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule

Goodwin on

On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more

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