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FDA Going Down ‘Pathway’ Of A Rule On LDTs, Califf Says

 
• By Brian Bossetta

During a webinar hosted by the Alliance for a Stronger FDA, commissioner Robert Califf said the agency was on the path to using its rulemaking authority to regulate laboratory-developed tests.

Califf at House Commerce Committee hearing on 8 Feb 2023
• Source: Screenshot

US Food and Drug Administration Commissioner Robert Califf has given his strongest indication yet that the agency is ready to act unilaterally on diagnostic regulatory reform.

“We’re going down the pathway of a rule,” Califf said during a webinar Tuesday hosted by the Alliance for a Stronger FDA. “Let me clear about that.”

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