Drugs

FDA Can’t Regulate AI on its Own: Califf

In an NPR interview, FDA commissioner Robert Califf says the field of artificial intelligence will be so big that FDA couldn’t possibly hire enough people to regulate it alone. “It’s very important that we get the clinical community, the health systems, the professions, the people you see for your healthcare, to be very involved in developing what we would call an ecosystem of regulation where these algorithms can be constantly evaluated,” he said.

Califf also made these points:

while clinical trials of algorithms can be useful, the decision support algorithms are changing daily and the key is to make sure they are safe at the beginning and then monitor them;
FDA is aware of the potential for bias in the formulation of an algorithm that can lead to biased output and make healthcare inequities even worse than they are; and
important healthcare decisions should be made by humans who know their patients and receive input and information from artificial intelligence, but not by an algorithm itself.

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