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In this issue of Quick Notes, we provide an eyebrow-raising peek at the European Medicines Agency’s newly announced 2025 marketing authorization fees as well as some insight on how the EU wants to ensure a steady supply of medical radioisotopes and two new Q&A docs — one for biosimilars and one for medical devices that incorporate a medicinal product. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Over seven hours of presentations, 50 stakeholders and members of the public voiced their opinions on the FDA’s advisory committee process, focusing often on diversity as well as patient and consumer perspectives in the panels, along with improved transparency and communications. Read More
The FDA, Health Canada and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued guiding principles for transparency for machine learning-enabled medical devices (MLMD). Read More
A part of an anesthesia system from Getinge that may dispense toxic gas and a cardiac balloon catheter from Teleflex/Arrow that may overtwist during use are both the subject of recalls that the FDA has deemed as Class I, the most serious recall as use of the devices may result in injury or death. Read More
This week, the FDA requested information and comments on enhanced drug distribution security requirements. The agency is also seeking nominations for its advisory committees and has amended the OTC monograph for analgesic, antipyretic and antirheumatic drugs. Read More
The FDA has established an Artificial Intelligence Program with a focus on six research topics that delve into the far-reaching implications of medical devices powered by AI and machine learning. Read More