Swissmedic has issued an important notice about the risks of intraoperative floppy iris syndrome (IFIS) among…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Swissmedic Updates on Veterinary Drug Reactions: Key Insights from 2024 Reports
The latest vigilance report from Swissmedic highlights significant findings regarding adverse reactions to veterinary medicinal products…
Swissmedic Advisory: Reduced Shelf Life for Lecigon (Carbidopa/Entacapone/Levodopa)
Swissmedic has issued a health professional communication regarding a change in the shelf life of Lecigon,…
FDA Releases Internal Filing Checklists to Streamline Drug Application Reviews
The U.S. Food and Drug Administration (FDA) has officially published internal filing checklists utilized by its…
Duplicate GTIN and EAN Numbers Raise Concerns for Relonchem Ltd Medicines
Healthcare professionals, regulators, and distributors should take note of a critical update related to Relonchem Ltd…
Urgent Recall: Incorrect Labelling Found in Accord Healthcare’s Ipratropium Bromide Nebuliser Solution
An urgent recall has been issued for Ipratropium Bromide 500 microgram/2ml Nebuliser Solution by Accord Healthcare…
Swissmedic Approves Initial Authorization for Sogroya®: Key Details for Regulatory Professionals
Swissmedic has announced the first authorization for Sogroya®, marking a significant regulatory development. The approval introduces…
Critical Updates: Field Safety Notices Issued for Medical Devices (13–17 October 2025)
Field Safety Notices (FSNs) issued between 13 and 17 October 2025 have been published, bringing critical…
Swissmedic Update: Revised EU Medical Device Regulations Explained
On October 21, 2025, Swissmedic announced updates to key sections related to EU legal acts for…
FDA Alert: Jody’s Inc. Recalls Sea Salt Caramel Cheddar Popcorn Due to Undeclared Peanuts
Jody’s Inc. has issued a nationwide recall of its Cabot Creamery Sea Salt Caramel Cheddar Popcorn…