内容摘要：. Using X-ray crystallography and cryogenic electron microscopy, his team captured detailed images of how mefloquine and aminoglycosides interact with the ribosome. These tools allowed the researchers to see where the drugs bind and how they change the ribosome’s behavior.

. Using X-ray crystallography and cryogenic electron microscopy, his team captured detailed images of how mefloquine and aminoglycosides interact with the ribosome. These tools allowed the researchers to see where the drugs bind and how they change the ribosome’s behavior.

, dubbed internally CDRH-GPT, is intended to help staffers at the agency’s Center for Devices and Radiological Health, a division responsible for ensuring the safety of devices implanted in the body as well as essential tools like X-rays and CT scanners.The division was among those affected by the

While many of the device reviewers were spared, the agency eliminated much of the backend support that enables them to issue approval decisions on time.The work of reviewers includes sifting through large amounts of data from animal studies and clinical trials. Depending on the applicant, it can take months or even over a year — which an AI tool could feasibly help shorten.Experts, however, are concerned that the FDA’s push toward AI could outpace what the technology is actually ready for.

Since taking over the agency on April 1, Commissioner Dr. Marty Makary has pushed to integrate artificial intelligence across the FDA’s divisions. How this move into AI could affect the safety and effectiveness of drugs or medical devices hasn’t been determined.for the AI rollout. On Monday, he said the agency was ahead of schedule.

But the two people familiar with CDRH-GPT say that it still needs significant work and that FDA staff were already concerned about meeting the June deadline, at least in its original form.

“I worry that they may be moving toward AI too quickly out of desperation, before it’s ready to perform,” said Arthur Caplan, the head of the medical ethics division at NYU Langone Medical Center in New York City. He stressed that reviewing medical devices accurately is essential, since people’s lives depend on it.Sloan Kettering “will consider this guidance in developing personalized treatment plans for each patient,” Nowak told KFF Health News.

The new NCCN guidance was “not the blanket recommendation we were working toward, but it is a major step toward our ultimate goal,” said Kerin Milesky, a public health official in Brewster, Massachusetts, who’s part of an advocacy group for testing. Her husband, Larry, died two years ago at age 73 after a single treatment of capecitabine.began urging oncologists to test patients for deficiency in May 2020. Patients with potentially risky genetics are started on a half-dose of the cancer drug. If they suffer no major toxicity, the dose is increased.

Emily Alimonti, a 42-year-old biotech salesperson in upstate New York, chose that path before starting capecitabine treatment in December. She said her doctors — including an oncologist at Sloan Kettering — told her they didn’t do deficiency testing, but Alimonti insisted. “Nope,” she said. “I’m not starting it until I get the test back.”The test showed that Alimonti had a copy of a risky gene variant, so doctors gave her a lower dose of the drug. Even that has been hard to tolerate; she’s had to skip doses because of low white blood cell counts, Alimonti said. She still doesn’t know whether her insurer will cover the test.