Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.

Affected users must identify, segregate, and quarantine the kits, add warning labels, and ensure the removal of the recalled components prior to use.

Companies must ensure compliance with the Irish language requirements and complete mandatory OMS registration before regulatory submissions to prevent delays.

Healthcare providers must utilize updated labels and ensure phosphate levels are monitored in at-risk patients and those receiving repeat therapy within three months.

Developers of NAMs are encouraged to participate in early dialogues with EMA and are now able to submit NAM-derived data for independent evaluation under a voluntary data submission pilot.

Healthcare professionals should not initiate treatment with Avacopan Vifor for new patients and must review existing patients' treatment plans to ensure safe transitions to alternative therapies.

Manufacturers must familiarize themselves with the new procedure, including creating an EMA account and understanding the timelines for submitting the required briefing documents according to the established timetable for 2025 and 2026.

Companies preparing 510(k) submissions for dental composite resin devices must align with the recommendations specified in the new guidance, which include detailed testing and labeling criteria.