On October 20, 2025, Swissmedic announced a temporary resolution to the supply shortage of Seroquel XR…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
FDA Alert: Jody’s Inc. Recalls Cabot Creamery Sea Salt Caramel Cheddar Popcorn Over Undeclared Peanut Risk
On October 17, 2025, Jody’s Inc., a Norfolk, Virginia-based company, announced the voluntary recall of its…
FDA Grants Historic National Priority Vouchers to Nine Sponsors Under New Pilot Program
The U.S. Food and Drug Administration (FDA) has announced a significant development in regulatory initiatives. On…
Swissmedic Announces Limited Distribution Approval for Opdivo 40 mg/4 ml Infusion Concentrate Amid Supply Challenges
Swissmedic has issued a temporary authorization permitting the distribution of Opdivo 40 mg/4 ml Konzentrat zur…
FDA Warns of Serious Risks Linked to Radiofrequency Microneedling Devices for Aesthetic Skin Procedures
The U.S. Food and Drug Administration (FDA) has issued a safety communication concerning serious complications associated…
Urgent Recall of Similasan Schnupfen Globuli Batch 17900 Announced by Swissmedic
On October 16, 2025, Swissmedic issued an urgent announcement regarding the recall of batch 17900 of…
Critical Updates on Field Safety Notices Issued from 6–10 October 2025
Between 6 October and 10 October 2025, several Field Safety Notices (FSNs) were published, signaling important…
Urgent Recall Issued for Nobivac DHPPi Veterinary Injection for Dogs
On October 15, 2025, Swissmedic announced a batch recall of the veterinary medicine Nobivac DHPPi, a…