Article Summary:
This week’s FDA update covers several regulatory developments. The agency announced a new pilot program to prioritize generic drug reviews, with a focus on applications involving domestic manufacturing and testing. The Center for Devices and Radiological Health also released its proposed guidance priorities for fiscal year 2026, including topics like validating diagnostic tests for emerging pathogens and using real-world evidence.
The major news this week is the ongoing government shutdown, which is expected to continue at least until next week as Congress has failed to reach an agreement on funding. This is impacting FDA operations, though the agency did manage to announce the new generic drug review pilot.
Other FDA actions include publishing draft guidance on adaptive clinical trial designs, sending safety reporting guidances to the OMB for review, and approving a second generic version of the abortion drug mifepristone. There were also some unusual developments, such as an FDA official expressing personal concerns about a drug on social media and the agency issuing warning letters and 483 observations to manufacturers.
On the device side, the FDA is expanding its Early Alert communications program and the industry group AdvaMed published guidance on managing remote medical devices. The agency also released a paper seeking public input on evaluating the real-world performance of AI-enabled medical devices.
Overall, this week saw a mix of routine regulatory updates alongside some more notable events, all while the government shutdown loomed in the background.