“Amy Abernethy, MD, PhD, is looking to the future. At a recent discussion on campus with cardiologist and researcher Mintu Turakhia, MD, Abernethy, the principal deputy commissioner of food and drugs and the acting chief information officer for the U.S. Food and Drug Administration, discussed her career path and how the FDA evaluates new technologies.”
“Attendees of her talk included software engineers, clinicians, and researchers, from technology, health care, and academia.”
“Abernethy began by describing her career, which led her from academia to a position as chief medical officer at Flatiron Health, an oncology technology firm, and then on to the FDA. She explained that her trajectory was the result of a question she kept asking herself: ‘How do we accelerate the process of clinical evidence generation?’”
“Academia, she explained, tended to be slow, and so she ‘took a right hand turn’ into industry to try to solve the same problems she’d been tackling in academic medicine. But after realizing that having clear regulatory guideposts was key to having the work go faster and that these guideposts were largely set by the government, she came to the FDA…”
“When the discussion moved to the new frontier of technology and device regulation, Abernethy reminded the audience that the Center for Devices and Radiological Health, a branch of the FDA, has jurisdiction over many medical devices and AI. Broadly, ‘the core principle is that we’re going to need to understand the performance of these products over time,’ she said. And that means taking the time to examine the data sets — and their underlying biases — behind the devices…” Read the full article here.
Source: Move quickly but safely: A view from inside the FDA – By Cassie Myers, September 16, 2019. Stanford Medicine Blog.
