Attention Clinicians: NOxBOX Ltd. Issues Critical Update for NOxBOXi Nitric Oxide Delivery System Over Dosing Concerns
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has issued a vital correction for its NOxBOXi Nitric Oxide…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Europe
Precautionary Recall of Fingolimod SUN 0.5mg by Sun Pharma: Capsule Breakage Risk Emerges
Sun Pharma UK Limited has issued a precautionary recall for one batch of Fingolimod SUN 0.5 mg hard capsules. This…
Europe
Feedback Requested: Consultation on SaMD ‘Predetermined Change Control Plans’ Closing December 2025
The Software as a Medical Device (SaMD) Working Group has invited stakeholders to review and comment on the draft document…
Latest News
Siemens Healthineers Corrects Critical Safety Issue with 3 Tesla MRI Systems
Siemens Healthineers has announced corrective actions for its 3 Tesla MRI systems, addressing a potentially severe safety risk that may…
Latest News
Critical FDA Alert: Sterile Medline Convenience Kits Recalled Due to Non-Sterilization
Healthcare professionals and supply managers, please be aware of an urgent recall announced by Medline Industries, LP. The company is…
Latest News
FDA Launches New Program to Accelerate Meeting Minutes Clarifications
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program aimed at enhancing communication with sponsors after…
Europe
Temporary Approval Issued for Selectol 200 mg Tablets in French Packaging
Swissmedic has issued a temporary authorization allowing the distribution of Selectol 200 mg film-coated tablets in French-language packaging. This regulatory…
Europe
Swissmedic Updates: New Measures to Address Suicide Risk with Finasteride and Dutasteride
On November 18, 2025, Swissmedic announced new measures to mitigate the risk of suicidal thoughts associated with the use of…
Europe
Swissmedic’s Multilingual Initiative: Vigilance-News Now Available in Four Languages
Swissmedic has announced an important update to its Vigilance-News publication, ensuring accessibility for a broader audience. Starting with Edition 35,…
Europe
Swissmedic Releases Haemovigilance Annual Report 2024 With Key Findings on Transfusion Safety
Swissmedic, the Swiss agency for therapeutic products, has published its Haemovigilance Annual Report for the year 2024. The report evaluates…
Latest News
FDA Adds High-Profile Warning to Elevidys Label Amid Fatal Liver Injury Reports
The U.S. Food and Drug Administration (FDA) has approved a significant update to the labeling of Elevidys (delandistrogene moxeparvovec-rokl), a…
Latest News
FDA Issues Guidance on Unauthorized Anti-Choking Devices: Follow Proven Rescue Protocols
The Food and Drug Administration (FDA) has issued an important update encouraging the public to use established choking rescue methods…
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