Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Users of affected products must conduct thorough visual inspections of the VentStar circuits prior to use and will receive free replacements for any affected circuits.

Philips is implementing a corrective safety action, and users must respond within 30 days to the included response form to address this safety concern. The modified cable expected to rectify the issue will be available by January 2027.

Marketing Authorization Holders must update packaging and compliance processes to incorporate QR codes linked to educational materials as per the new guidelines.

Monitor compliance practices regarding PAVA use in youth custody settings and assess alignment with the YJB's concerns and evidential claims on efficacy and safety.

Regulatory intelligence should be updated to reflect the new PSUSA, and signal management processes may require reviews based on new safety information.

Update product labels to include prevention indications for Capstar and Nitenpyram Tablets. Ensure that labeling reflects new usage guidelines for these products as outlined in the Emergency Use Authorization.

Review compliance with PREA obligations, prepare responses to any received non-compliance letters, and ensure any necessary deferral extension requests are properly submitted within the specified timeframe.

Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.