Key Updates in Field Safety Notices: Impact on Medical Devices and Compliance
Between 27 and 31 October 2025, several Field Safety Notices (FSNs) were issued, highlighting critical updates for medical device safety…
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258 articles in Europe
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Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure a state-of-the-art Document and…
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Swissmedic Publishes November Safety Updates for Healthcare Professionals
Swissmedic has issued new safety-related updates this November 2025, designed to inform healthcare professionals and regulatory teams about important changes…
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Swissmedic Updates Key Information on Drug Safety Reporting – What You Need to Know
Swissmedic has announced an update to its Drug Safety Reporting Duties in Switzerland information sheet. The adjustments include revised contact…
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Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM process, effective November 1,…
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Urgent Recall Alert: Baxter Healthcare’s Hartmann’s Solution Packaging Mix-up
Baxter Healthcare Limited has issued a Class 2 medicines recall after identifying a packaging error involving their Compound Sodium Lactate…
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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 the latest insights and…
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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 review by clinical, quality,…
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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 pivotal event in the…
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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 its Laboratory Department, particularly…
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Swissmedic Authorises New Therapeutic Use for Trecondi®
Swissmedic has announced an update regarding the medication Trecondi®. On October 31, 2025, the regulatory body extended the drug’s therapeutic…
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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. This development is relevant…
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