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Califf Sits Down For Fireside Chat; Looks Back And Ahead

 
• By Brian Bossetta

Robert Califf marked his one-year anniversary as the commissioner of the US Food and Drug Administration by discussing the first year of his second term as the agency’s chief executive and his vision for the future.

Robert Califf in fornt of FDA building
• Source: Shutterstock

Running the US Food and Drug Administration is nothing new for Robert Califf, who took the reins of the agency in February 2022. A cardiologist by trade, Califf also ran the agency in the final year of the Obama administration. But, he noted during a recent fireside chat hosted by the Alliance for a Stronger FDA, that was a more “genteel” time.

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Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

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More from Policy & Regulation

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

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New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.