Global updates on medical device regulation and quality.
441 articles
Meta description: This update enhances patient and clinician risk communication by presenting clear safety guidance across six menopausal hormone therapy…
Publication date: February 12, 2026. The U.S. Food and Drug Administration has approved Optune Pax for adult patients with locally…
Publication date context: 2026-02-12 05:04:14 UTC. The U.S. Food and Drug Administration released a new approach to support the transition…
Meta description: The FDA announces plans to restrict GLP1 APIs used in non FDA approved compounded drugs mass marketed by…
Published: 2026-02-11 Regulatory teams and medical device professionals should note the upcoming archiving of information sheets on specimen texts for…
As of February 11, 2026, Swissmedic has comprehensively revised the Guidance document Drug Safety Signals HMP, modifying its structure and…
As of 1 February 2026, a revised list of variations according to Articles 21-24 of the Swiss Therapeutic Products Ordinance…
Meta Description: Swissmedic reports significant non-conformities in wrinkle treatment using medical devices. Published: 2026-02-11 Swissmedic’s recent focus campaign on therapeutic…
Temporary authorization for distribution in German packaging A recent announcement by Swissmedic highlights a significant development in the distribution of…
As of February 11, 2026, Swissmedic announced a recall of Similasan Schlafstörungen Globuli due to quality issues affecting the product’s…
The Jarisch-Herxheimer Reaction An adverse reaction to antibiotic treatment for spirochaetal infections, the Jarisch-Herxheimer reaction is a phenomenon clinicians should…
On February 11, 2026, Swissmedic announced the extension of the therapeutic indication for Fabhalta, a medical device used in various…