Drugs

Balance AI Optimism and Pessimism: Califf

FDA commissioner Robert Califf says artificial intelligence (AI), like many of the great innovations for humankind, can be used for tremendous good or tremendous harm. In a wide-ranging Medscape interview, Califf says it’s always good to have in the back of one’s mind that harm can be done.

“I’ve lived my whole career,” he said, “working with people developing new treatments. And if you’re excited about the treatment, you may not see the downside. It’s just in my nature to think about the potential downside, but I’m very excited about the upside.”

Asked if he could foresee a time when AI would be used as part of the drug review process, Califf said the short answer is yes and he would not be at all surprised to see AI tools as part of drug review.

Asked whether obesity is primarily a biological disease, Califf said human biology hasn’t changed that much from generation to generation but people are more obese now than they were. He said there also has to be a behavioral component. You can improve obesity by manipulating the circuits between the gut and the brain, Califf said. “It seems like every trial that is coming in is looking better and better,” he added. “I always have to say that we need the big trial data for people with obesity without diabetes. And those trials are underway and will soon be coming.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome