The U.S. Food and Drug Administration (FDA) has officially published internal filing checklists utilized by its…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
Temporary Authorization Issued for Seroquel XR 50 mg Tablets in Italian Packaging
On October 20, 2025, Swissmedic announced a temporary resolution to the supply shortage of Seroquel XR…
Swissmedic Grants Initial Approval for Imcivree®: What You Need to Know
Swissmedic has officially granted the initial authorisation for Imcivree®. This significant regulatory decision is vital for…
FDA Alerts: Publix Vanilla Ice Cream Recall Due to Undeclared Egg Allergen
On October 15, 2025, Publix Super Markets issued a voluntary recall of its Rich & Creamy…