How to write clear and effective field safety notices (FSNs) for medical devices.
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The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice.
MHRA approves zanidatamab (Ziihera) for the treatment of biliary tract cancer
Zanidatamab is used when the cancer cannot be removed by surgery and has spread to nearby tissues or other parts of the body.
Class 4 Medicines Defect Notification: Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company, EL(25)A/41
Chanelle Medical Unlimited Company has informed the MHRA of an error with the European Article Number (EAN) / Global Trade Item Number (GTIN) barcode on certain batches of Fexofenadine Hydrochloride 120mg film-coated tablets, distributed by Healthcare Pharma Limited.
Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices
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