Swissmedic has announced a recall of batch B323BE of Amoxicillin OrPha 1g powder for injection or…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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…
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…
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…
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…
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…
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.…
Swissmedic Reaffirms Titanium Dioxide Use in Medicinal Products
On November 5, 2025, Swissmedic announced that titanium dioxide will remain authorized as an excipient for…
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…