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Q&A: FDA Chief Califf Talks Clinical Trial Diversity, Using AI/ML For Inspections, User Fees, And More

 
• By Shawn M. Schmitt

The commissioner of the US agency, Robert Califf, answered questions on a variety of timely issues at a 12 July fireside chat. Here are three key takeaways for medtech.

Food and Drug Administration Commissioner nominee Doctor Robert Califf testifies at his nomination hearing at the Senate Health, Education, Labor and Pensions Committee on Capitol Hill in Washington, November 17, 2015. REUTERS/Gary Cameron
• Source: Reuters/Gary Cameron

Robert Califf, the commissioner of the US Food and Drug Administration, is concerned that a laser focus on ensuring diversity in clinical trials is a sideshow from the real problem: “lack of equity in our health care system.”

Speaking at a 12 July fireside chat sponsored by the Alliance for a Stronger FDA, the agency head said that if the disparity was fixed and health

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