EMA CHMP Agenda: Hetlioz for Smith-Magenis Syndrome
The European Medicines Agency (EMA) has published the agenda for an extraordinary CHMP meeting on March 16, 2026. The agenda includes discussions on the re-examination procedure for Hetlioz (Tasimelteon) for Smith-Magenis Syndrome, involving oral explanations and variations to marketing authorisations.
COVID-19 Vaccines: Safety Profile Confirmed
The French National Agency for the Safety of Medicines and Health Products (ANSM) has confirmed the safety profile of COVID-19 vaccines. The agency stated that no new safety signals have been identified, reinforcing the established safety of these vaccines.
HHS OIG Audit of Gateway Health Plan Medicare Advantage Compliance
The HHS Office of Inspector General (OIG) audited Gateway Health Plan, Inc.'s submission of diagnosis codes to CMS for Medicare Advantage risk adjustment. The audit found that most sampled diagnosis codes were not supported by medical records, leading to an estimated $4.3 million in net overpayments for 2018 and 2019.
Stryker Osteosynthesis Screws Recalled Due to Safety Concerns
The French ANSM has announced a recall of Stryker osteosynthesis screws (7.0 mm Darco headless screws, 16x60 mm) due to safety concerns. This action, registered under recall number R2606623, affects pharmacies and users who have received direct communication from Stryker Instruments.
Polysilane UPSA gel oral recall notice
The ANSM has issued a recall notice for specific lots of Polysilane UPSA oral gel due to the potential presence of food-grade joint particles. The recall is a precautionary measure affecting the distribution chain, and the product will be unavailable until the issue is resolved.
Product Recall: Mako Surgical Corp. MICS3 Fixation Device
The ANSM has announced a product recall for the Mako Surgical Corp. MICS3 fixation device, registered under recall number R2606434. The recall targets pharmacies and healthcare facilities, with two identified users having received direct communication from the manufacturer.
Neonatal incubator safety alert: Lifetherm 2000
The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.
Impella AIC consoles with software <10.1 and Impella 5.5 first-gen safety alert
The ANSM has been informed of a safety action by Abiomed concerning Impella AIC consoles with software versions prior to 10.1, when used with first-generation Impella 5.5 ventricular assist devices. Healthcare providers using these devices have received specific instructions from Abiomed.
FDA Mammography Standards Quality Act Requirements Comment Request
The FDA has submitted a proposed collection of information related to Mammography Quality Standards Act requirements to the Office of Management and Budget (OMB) for review. The agency is requesting public comments on this information collection, with a deadline of April 13, 2026.
FDA Variance Application from William Moore - Public Comment
The FDA is accepting public comments on a variance application submitted by William Moore. The comment period is open until March 13. This action pertains to a specific application for a variance.
FDA Variance Application from Low Frequency Productions
The FDA is accepting comments on a variance application submitted by Low Frequency Productions. This application pertains to medical device regulations. The comment period for this application closed on March 13.
FDA Variance Approval for North Bay Productions
The FDA has issued a variance approval letter to North Bay Productions. This document, originating from the CDRH, signifies an approval related to a specific variance request.