Regulatory Update: Swissmedic Confirms Morphinum Capsule Integrity Issues
On November 10, 2025, Swissmedic issued an important notification regarding Sevre-Long® (morphinum), a prescription medication commonly used for pain management.…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Europe
Swissmedic Issues Recall for Amoxicillin OrPha 1g Due to Quality Concerns
Swissmedic has announced a recall of batch B323BE of Amoxicillin OrPha 1g powder for injection or infusion. The recall affects…
Latest News
Fresenius Kabi Recalls Famotidine Injection Due to Elevated Endotoxin Levels in Reserve Samples
On November 6, 2025, Fresenius Kabi announced a voluntary nationwide recall of three lots of Famotidine Injection, USP, 20 mg…
Europe
First Swissmedic Authorisation for KIMMTRAK®: A Key Milestone in Oncology Therapy
Swissmedic has released a pivotal regulatory announcement regarding the authorisation of KIMMTRAK®, marking its first approval for clinical use. This…
Europe
Swissmedic Announces Extension of Indication for Retsevmo®: Regulatory Update
On November 7, 2025, Swissmedic officially announced the extension of the therapeutic indication for Retsevmo®, a key development for clinical,…
Latest News
FDA Cracks Down on Illegal Marketing of Unapproved Botulinum Toxin Products
The U.S. Food and Drug Administration (FDA) has issued formal warnings to 18 website owners found marketing unapproved and misbranded…
Latest News
FDA Expands National Priority Voucher Program With Six New Awardees
The U.S. Food and Drug Administration (FDA) has announced six additional recipients of the Commissioner’s National Priority Voucher (CNPV) pilot…
Europe
Swissmedic Annual Report: GCP Inspections in Clinical Trials Highlight Key Compliance Areas
Swissmedic has released its annual report detailing the results of clinical trial inspections conducted as part of Good Clinical Practice…
Europe
Swissmedic Approves PulmoProDiff®: A Notable Step in Respiratory Diagnostics
Swissmedic has announced the official authorisation of PulmoProDiff®, marking a critical milestone in respiratory diagnostic technology. Clinical, regulatory, and quality…
Europe
Swissmedic Reaffirms Titanium Dioxide Use in Medicinal Products
On November 5, 2025, Swissmedic announced that titanium dioxide will remain authorized as an excipient for use in medicinal products…
Europe
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…
Latest News
Olympus Updates Laser Bronchoscope Instructions Following Safety Concerns
Olympus Corporation has announced an important voluntary labeling update for bronchoscopes used with laser therapy, argon plasma coagulation, and high-frequency…
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