Baxter Healthcare Limited has issued a Class 2 medicines recall after identifying a packaging error involving…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
October 2025 MHRA Safety Bulletin: Critical Updates for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its October 2025 safety update, detailing…
Clinical Teams: Significant Updates on Medical Device Field Safety Notices (20–24 October 2025)
Field Safety Notices (FSNs) issued between 20 and 24 October 2025 have recently been compiled for…
FDA Issues Warning on Elevated Risk of Device Failure for Hintermann Series H3 Total Ankle Replacement
The U.S. Food and Drug Administration (FDA) has released an updated safety communication regarding the Hintermann…
Swissmedic Grants Initial Authorisation for Filsuvez®: A Key Milestone in Advanced Therapies
Swissmedic, the Swiss agency for therapeutic products, has announced the first authorisation of Filsuvez®, marking a…
Swissmedic Announces New Role for Laboratory IT Systems Specialist in OMCL
Swissmedic, Switzerland’s surveillance authority for medicines and medical devices, has disclosed an exciting new opportunity in…
Swissmedic Authorises New Therapeutic Use for Trecondi®
Swissmedic has announced an update regarding the medication Trecondi®. On October 31, 2025, the regulatory body…
Swissmedic Grants First Authorisation for SWAN-PSMA-1007®: Key Regulatory Insights
On October 31, 2025, Swissmedic announced the first authorisation of SWAN-PSMA-1007®, marking a significant regulatory milestone.…
Swissmedic Updates Position Paper on Decentralised Clinical Trials: Key Changes Explained
On October 31, 2025, Swissmedic and swissethics announced an update to their position paper on decentralised…
Swissmedic Approves Extended Therapeutic Indication for Omvoh®
Swissmedic has announced an important update regarding the therapeutic scope of Omvoh®. The newly approved indication…