List of Field Safety Notices from 15 to 19 September 2025.
Similar Posts
Clinical trials regulations: transitional arrangements
Guidance on transitional arrangements for applying for clinical trial approval.
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.
Designated standards prioritisation
The MHRA invite feedback on the use of designated standards for medical devices and in vitro diagnostic (IVD) devices to help shape future initiatives.
Guidance: Paclitaxel drug-coated balloons and drug-eluting stents
Recommendations from the independent Expert Advisory Group to the MHRA on the use of paclitaxel balloon catheters and stents to treat peripheral arterial disease.
Guidance: Risk minimisation measures for medicines
Guidance for healthcare professionals on risk minimisation options for medicines.
Policy paper: Rare therapies and UK regulatory considerations
A paper outlining MHRA’s intentions to make it quicker and easier to get rare disease therapies tested, manufactured and approved in the UK.