On October 17, 2025, Jody’s Inc., a Norfolk, Virginia-based company, announced the voluntary recall of its…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
Swissmedic Highlights Regulatory Focus on Parenteral Cosmetic Products
Swissmedic has released key insights on parenteral products in the cosmetic sector. This update, published on…
FDA Issues Boxed Warning Update for CARVYKTI Over Rare Enterocolitis Risk
The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a…
Urgent FDA Alert: Cybersecurity Vulnerability Identified in Abiomed’s Automated Impella Controller
On October 10, 2025, the FDA issued an alert regarding a cybersecurity vulnerability affecting the Automated…