List of Field Safety Notices from 16 to 20 June 2025.
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Side effects from drug interactions to be predicted by AI before reaching patients
The MHRA leads three new government-backed projects using AI-driven approaches to make medicines safer and bring treatments to patients more quickly.
Field safety notices: guidance for manufacturers
How to write clear and effective field safety notices (FSNs) for medical devices.
Field Safety Notices: 1 to 5 September 2025
List of Field Safety Notices from 1 to 5 September 2025.
Device specific vigilance guidance: Coronary Stents and associated delivery systems
Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.
M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis
The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.