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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

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• By Amanda Maxwell

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Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.