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
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
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
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
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
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,
FDA Issues Warning on Elevated Risk of Device Failure for Hintermann Series H3 Total Ankle Replacement
The U.S. Food and Drug Administration (FDA) has released an updated safety communication regarding the Hintermann Series H3 Total Ankle
Safety Alert: Recall of NaCl B. Braun Infusion Solution Batch
Swissmedic has issued an announcement regarding the immediate recall of batch number 251347651 of NaCl B. Braun infusion solution. This
New Clinical Trial Tests Non-FDA Approved Medical Device: What You Should Know
On October 31, 2025, new developments emerged regarding a clinical trial involving a medical device that has not yet received
Evaluating ‘DRISTi’: The Future of Diabetic Retinopathy Screening with AI
The potential of ‘DRISTi’, an AI-powered screening tool for diabetic retinopathy (DR), is being explored in a new clinical trial