A mobile app that controls an insulin pump has been recalled for a software problem that potentially leads to crash of the app and pump battery depletion. Source: Drug Industry…

Clarity on the definition of “remanufacturing” for reusable medical devices needing maintenance or repair is the focus of a final guidance the FDA issued on Thursday. Source: Drug Industry Daily

The FDA and NIH are asking stakeholders for support in developing a glossary of terms related to clinical trial innovation especially for terms involving real world data (RWD) and real…

A major agency-wide reorganization affecting regulatory affairs and medical products, and more than $12 million to tackle supply chain issues across all products areas, were included in the FDA’s FY…

After enduring several setbacks, Lilly will pitch its antiamyloid contender donanemab to the Peripheral and Central Nervous System Advisory Committee in a June 10 meeting. Source: Drug Industry Daily

China-based Bioptimal International removed the heparin coating from the tubing for its thermodilution catheter without seeking FDA clearance for the device, earning the company a Warning Letter following a Nov.…

Patients with two copies of the Alzheimer’s high-risk gene apolipoprotein e4 (APOE4) are more likely to develop the biological characteristics that define Alzheimer’s disease, a finding that could have important…

The United Kingdom’s medicines and medical devices regulator has unveiled its approach to AI in a report presented to the UK government, urging transparency, inclusivity and aligning with partners globally…

FDA advisory meetings, which since COVID have been tackled online, are returning to in-person status, said CDER Director Patricia Cavazzoni. Source: Drug Industry Daily

Five EU regulatory authorities have published a joint plan to support the implementation of the One Health agenda in the EU, a plan help prevent and respond to health threats.…