The U.S. FDA announced enhanced transparency measures, committing to release complete response letters (CRLs) in real time shortly after sponsor receipt. This move follows July’s unprecedented public release of over 200 CRLs. Additionally, the FDA has proposed increased unannounced inspections of foreign drug manufacturing sites aiming to strengthen oversight. The agency also cleared Respiree Pte. Ltd.'s RS-001 cardio-respiratory wearable for passive home monitoring. Moreover, the FDA recalled Abbott’s Heartmate 3 power supply due to power cord detachment risks that could lead to critical battery depletion during device use.