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.…

HHS leadership and coordination challenges with handling public health emergencies, particularly its management of the Strategic National Stockpile (SNS), was scrutinized in a Government Accountability Office (GAO) report resulting in…

This edition of Quick Notes reviews the FDA’s 510(k) clearance of a ZygoFix spinal fusion device, GE Healthcare’s vital signs monitor, an EEG monitoring system and AI for event detection…

A 10-item Form 483 called out multiple problems with expired or non-pharmaceutical grade products, lack of written procedures and records, and an inadequate quality control unit at Maryland-based Aerosol and…

NDAs, ANDAs and BLAs need to incorporate risk evaluation and mitigation strategies (REMS) with clear goals, objectives, and strategies that align with the intended outcomes not only for the design…