Regulatory Affairs

Urgent Swissmedic Batch Recall: Lexotanil 3mg Tablets

On 26 November 2025, Swissmedic issued an official notice regarding the immediate recall of batch 1653102 of Lexotanil 3mg Tablets.…

Swissmedic Grants Initial Authorisation for Tepezza®: Key Implications for Regulatory Teams

Swissmedic announces the first authorisation of Tepezza®. This development is significant for quality, clinical, and regulatory professionals monitoring approvals of…

Swissmedic Authorizes Temporary Distribution of Glucose 5% Infusion Solution in German Packaging

Swissmedic has announced a temporary approval for the distribution of Glucose 5% B. Braun Infusionslösung in German packaging. This decision…

Swissmedic Approves Temporary Distribution of NaCl 0.9% Infusion in Foreign Packaging

On November 26, 2025, Swissmedic announced the temporary approval for distribution of NaCl 0.9% infusion solution from B. Braun in…

Canada

Health Canada Aligns with IMDRF Standards for Medical Device Applications

In a significant step toward global regulatory alignment, Health Canada has announced it is adopting the International Medical Device Regulators…

Critical Updates: Field Safety Notices Issued for Medical Devices (Nov 17–21, 2025)

New updates on medical device safety concern all clinical, quality, and regulatory professionals. Between November 17 and November 21, 2025,…

Important Safety Notice: Updated Safety Information Missing from Moclobemide 150mg Tablets Packaging

On November 25, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4 Medicines Defect Notification regarding…

FDA Warns About Potential Reverse Flow Issue in Fresenius Kabi Large Volume Pump Sets

The FDA has issued an Early Alert regarding a potential high-risk issue with certain Fresenius Kabi Ivenix Large Volume Pump…

Urgent Recall of SpeedControl Dials for SmartDrive MX2+ Power Assist Devices Due to Safety Hazards

Max Mobility/Permobil has initiated an urgent recall of SpeedControl Dials used in their SmartDrive MX2+ Power Assist Devices. This action…

Swissmedic Announces Financial Consolidation Plan Amid Regulatory Priorities

Swissmedic, Switzerland’s key regulatory authority for therapeutic products, has outlined measures to strengthen its financial position. The announcement made 25…

Supreme Deli LLC Recalls Boar’s Head Pecorino Romano Cheese Over Listeria Risks

Supreme Deli LLC, conducting business as Supreme Service Solutions, has announced a voluntary recall of specific Boar’s Head Pecorino Romano…

FDA Grants Approval for Gene Therapy Addressing Spinal Muscular Atrophy Treatment Needs

The U.S. Food and Drug Administration (FDA) has officially approved Itvisma (onasemnogene abeparvovec-brve), a gene therapy developed for patients with…