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FDA Set To Drop Final Rule On LDTs, Sends Draft To White House

 
• By Brian Bossetta

The US FDA has delivered a draft of its final rule on regulating lab-developed tests to the Office of Management and Budget, signaling it could meet the White House’s expectation for publishing its final rule by April.

Coming Soon
• Source: Shutterstock

Since the Food and Drug Administration issued a proposed rule that will place laboratory developed tests (LDTs) under its regulatory purview in October, the question has been how long it would take for the agency to deliver its final rule.

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