Posts by PacConAdmin

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 2025 budget proposed to a Senate Appropriations subcommittee Wednesday morning by Commissioner Robert Califf. Source: Drug Industry Daily

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. 6, 2023, inspection of the company’s Singapore facility. Source: Drug Industry Daily

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 implications in drug design and clinical trials. Source: Drug Industry Daily

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 among its key published principles. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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 recommendations for improvement. Source: Drug Industry Daily

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 by Epitel, and BMF cosmetic dental veneers. Source: Drug Industry Daily

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 Liquid Packaging. Source: Drug Industry Daily