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 updates for clinical, quality,…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Europe
Swissmedic Update: Revised EU Medical Device Regulations Explained
On October 21, 2025, Swissmedic announced updates to key sections related to EU legal acts for medical devices. These revisions…
Latest News
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 (6 oz bags) due…
Europe
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 50 mg retard tablets…
Europe
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 stakeholders in the clinical,…
Latest News
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 Vanilla Ice Cream in…
Latest News
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 Cabot Creamery Sea Salt…
Latest News
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 October 18, 2025, the…
Europe
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 Herstellung einer Infusionslösung in…
Latest News
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 with the use of…
Europe
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 Similasan Schnupfen Globuli (15g),…
Europe
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 updates and concerns for…
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