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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that align with the intended outcomes not only for the design of the REMS but also for future modification, a new FDA draft guidance says.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
The overall quality of data and risk of potential bias in them should be top of the mind for European sponsors who want to employ real-word data (RWD) in non-interventional studies (NIS), according to a reflection paper released by the European Medicines Agency. Read More
The FDA’s CDER has released 2023 Annual Reports for its Offices of New Drugs (OND) and Translational Sciences (OTS), highlighting activities that span dozens of drug approvals and guidances from developing AI-enabled software prototypes to identify adverse drug events. Read More