Olympus Corporation has announced an important voluntary labeling update for bronchoscopes used with laser therapy, argon…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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.…
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…
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…
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…
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,…
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…
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…
Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM…