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.
Mako Surgical Corp. MICS3 Sagittal Saw Fixation Device Recall
ANSM registered safety action R2606434 following a lot withdrawal initiated by Mako Surgical Corp. for its MICS3 fixation device for computer-assisted sagittal saw surgery. The two affected users received direct notification from the company on 16 March 2026. This field safety corrective action is directed to hospital pharmacies and health establishments and recorded under ANSM's internal reference R2606434.
Impella AIC Console Software and Impella 5.5 First-Generation Safety Alert
ANSM has informed healthcare establishments of a safety action taken by Abiomed concerning automated Impella AIC consoles running software versions prior to 10.1, used in combination with first-generation Impella 5.5 ventricular assist devices. The safety action was implemented following identification of a device-specific safety concern. Users have received direct correspondence from Abiomed with further instructions. The alert is registered at ANSM under reference number R2606924.
Neonatal Incubator Safety Alert: Lifetherm 2000 by Löwenstein Medical
ANSM has been informed of a safety action implemented by Löwenstein Medical GmbH & Co. KG regarding the Lifetherm 2000 neonatal incubator. The action, registered under reference number R2607231, was communicated to the single affected healthcare establishment via a letter dated 16 March 2026. ANSM advises stakeholders to direct enquiries to the originator of the safety action for further information.
Stryker Instruments Orthopedic Headless Screws 7.0 mm Darco 16x60 Recalled
Stryker Instruments has implemented a lot withdrawal action for headless orthopedic screws (Darco 7.0 mm, reference 16x60), recorded by ANSM under recall number R2606623. Hospital pharmacies with usage authorization have received direct notification from the firm. Users are instructed to contact Stryker Instruments directly for information regarding this safety action.
UPSA SAS Recalls Polysilane Gel Oral Sachets Over Particle Contamination
Laboratoire UPSA SAS, in agreement with ANSM, is recalling multiple lots of Polysilane UPSA gel oral in sachet-dose (box of 12 sachets, CIP 34009 336 575 9 8) from the distribution chain. The recall affects 41 lots spanning expiration dates from March 2026 through October 2028, covering lot numbers C009–C019, F001–F017, and L002, L007–L019. The action follows detection of possible food-quality gasket particles (approximately 1mm) in certain sachets; ANSM states these particles present no specific toxicity and no pharmacovigilance cases have been reported. The product will be unavailable until UPSA resolves the manufacturing issue.
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.
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 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.