Other

Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.

Consumers must stop taking the product immediately and return remaining capsules to a pharmacy for safe disposal.

Stop using and dispose of Pharmatech MK-677 capsules immediately; consult a healthcare professional if concerned.

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.

Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.

Review product inventory for Tawon Liar; report any adverse events to FDA MedWatch; consider adding product to signal monitoring list; ensure labeling compliance checks for similar products.

Establish compliant storage conditions for medical devices and set up a non-conformity management system within 3 months.

Healthcare providers and compounding facilities should implement the new temporary policies under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act to ensure compliance and access to essential nutrition products.

The program will implement collaborative processes for the evaluation of technologies, enhancing real-world evidence integration into signal management and impacting regulatory compliance workflows.

Surgifrance must implement corrective actions, including the establishment of processes for handling complaints in 3 months, and a complaints register within 8 months.

Pharmacovigilance systems must be updated to monitor and report on the newly added medications.

Ongoing investigations into unlawful vaping products are expected to result in further enforcement actions, including additional seizures and potential penalties for non-compliance with the Therapeutic Goods Act.

Regulatory intelligence workflows should address this enforcement action as part of ongoing compliance monitoring regarding the sale and promotion of unapproved therapeutic goods.

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.