Nationwide Recall of Mislabelled Potassium Chloride Injection – Critical FDA Update
Clinical professionals, regulatory teams, and healthcare providers should note the recent voluntary nationwide recall of a potassium chloride injection product.…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Latest News
FDA Moves to Halt Sale of Unapproved Fluoride Prescription Drugs for Children
The FDA has taken a significant step to protect children from unapproved ingestible fluoride prescription products. Announced on November 3,…
Latest News
Nationwide Recall Issued for Mislabelled Potassium Chloride Injection by Otsuka ICU Medical LLC
Otsuka ICU Medical LLC has announced a voluntary nationwide recall of a specific lot of potassium chloride injection due to…
Latest News
Critical Labeling Update Issued for Olympus Bronchoscopes Used in Laser Therapy Procedures
Olympus Corporation has announced a voluntary corrective action involving bronchoscopes used in conjunction with certain high-risk therapeutic procedures. This update…
Europe
Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure a state-of-the-art Document and…
Latest News
FDA Restricts Sale of Unapproved Fluoride Prescription Drugs for Children’s Safety
The U.S. Food and Drug Administration (FDA) has announced significant regulatory steps to enhance child safety, restricting the sale of…
Europe
Swissmedic Publishes November Safety Updates for Healthcare Professionals
Swissmedic has issued new safety-related updates this November 2025, designed to inform healthcare professionals and regulatory teams about important changes…
Europe
Swissmedic Updates Key Information on Drug Safety Reporting – What You Need to Know
Swissmedic has announced an update to its Drug Safety Reporting Duties in Switzerland information sheet. The adjustments include revised contact…
Europe
Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM process, effective November 1,…
Europe
Urgent Recall Alert: Baxter Healthcare’s Hartmann’s Solution Packaging Mix-up
Baxter Healthcare Limited has issued a Class 2 medicines recall after identifying a packaging error involving their Compound Sodium Lactate…
Europe
October 2025 MHRA Safety Bulletin: Critical Updates for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its October 2025 safety update, detailing the latest insights and…
Europe
Clinical Teams: Significant Updates on Medical Device Field Safety Notices (20–24 October 2025)
Field Safety Notices (FSNs) issued between 20 and 24 October 2025 have recently been compiled for review by clinical, quality,…
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