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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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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that align with the intended outcomes not only for the design of the REMS but also for future modification, a new FDA draft guidance says. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, thathas been acted on since Oct. 1, 2023 to keep you updated on laws andregulations that could impact your business. Read More