On November 7, 2025, Swissmedic officially announced the extension of the therapeutic indication for Retsevmo®, a…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
Olympus Updates Laser Bronchoscope Instructions Following Safety Concerns
Olympus Corporation has announced an important voluntary labeling update for bronchoscopes used with laser therapy, argon…
Nationwide Recall of Mislabelled Potassium Chloride Injection – Critical FDA Update
Clinical professionals, regulatory teams, and healthcare providers should note the recent voluntary nationwide recall of a…
FDA Moves to Halt Sale of Unapproved Fluoride Prescription Drugs for Children
The FDA has taken a significant step to protect children from unapproved ingestible fluoride prescription products.…