FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More
• By Sue Darcey
FDA's device center 'has a lot of work ahead of us,' to implement not only the 21st Century Cures Act, but also maintain performance goals for device and drug reviews, speakers said at a Food Drug Law Institute meeting May 5. The agency released a proposed work plan for use of 'Cures' Innovation Account funds, with dollars detailed for the device side on breakthrough devices, humanitarian device exemptions, and least burdensome device provisions, among others, as spelled out for use at a May 8-9 Science Board meeting.
US FDA's device center has "a lot of work ahead of us" to respond to the new provisions enacted Dec. 13 in the 21st Century Cures Act, says Jonette Foy, acting associate director for policy of FDA's Center for Devices and Radiological Health.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.
