Swissmedic, Switzerland’s authority for medical devices and therapeutic products, announces an exciting cloud engineering position. Key…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Rolls Out Advanced AI Tools for Enhanced Regulatory Operations
The U.S. Food and Drug Administration (FDA) has announced a significant milestone: the organization is deploying…
FDA Issues Urgent Recall for SJM Pericardial Patch Due to Quality Control Issue
An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed…
Swissmedic Updates Guidance: Packaging Leaflets for Healthcare-Only Medicines Optional
Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its…
Temporary Approval Announced for Sales of Opdivo 240 mg Infusion Solution in Italian Packaging
Swissmedic has issued a temporary approval enabling the distribution of Opdivo 240 mg/24 ml concentrate for…
Swissmedic Grants Temporary Approval for Nemluvio Injection Pen Packaging in German
Swissmedic has announced the temporary authorization of Nemluvio—or Nemluvio Pulver und Lösungsmittel zur Herstellung einer Injektionslösung…
International Council for Harmonisation Convenes: Regulatory Updates for Pharmaceuticals Highlighted
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) convened its…
Medicine Safety Alert: Baclofen 10mg Tablets Missing Correct Patient Safety Information
A safety advisory has been issued for Baclofen 10mg tablets, manufactured by Special Concept Development UK…
Regulatory Update: MHRA Highlights November 2025’s Key Safety Insights for Medicines and Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its latest safety roundup for November…
FDA Issues Serious Correction Notification for BD Alaris Pump Modules Due to Safety Risks
The United States Food and Drug Administration (FDA) has released an updated correction notification for BD…