MTI Profile: US FDA's Second-In-Command Has Her Eye On A Tech-Forward Future
As principal deputy commissioner of the FDA, Amy Abernethy is focused on developing overarching policies that affect all its product centers. But perhaps what will stand as her legacy is her work to develop a data-centered strategy to improve how the agency reviews products and ensures their long-term safety and efficacy.
You may also be interested in...
US FDA principal deputy commissioner Amy Abernethy is set to leave the agency by the end of April. The surprise news comes in the midst of the Biden administration still figuring out who they want to lead the FDA.
The US agency says its medical device program is in desperate need of an information technology upgrade, noting that its outdated IT systems, tools and approaches could leave it flat-footed when dealing with cybersecurity threats and ever-evolving medtech. That’s why the FDA is asking Congress for $18m to tackle the IT sore spot.
Amy Abernethy, the principal deputy commissioner at the US FDA, told attendees at a 25 July medical conference that she's somewhat skeptical about using wearable technologies for clinical needs because they still haven’t proven their accuracy. However, she says the device center is working hard to develop new standards for such products and is looking for funding to develop them.