Tga.gov.au

Regulatory Intelligence teams must initiate checks to monitor compliance and management of this recall, ensuring affected lots are removed from distribution.

Regulatory teams must update product labeling to reflect the new indication and assess signal management considerations for capivasertib.

Health professionals and stakeholders should review the safety signals linked to CAROTONE products in their signal management processes.

Ensure compliance checks are reinforced in the inspection readiness processes to account for potential non-compliance surrounding product imports.

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.

Organizations must enhance signal management processes to track and report adverse events related to Melanotan II products, ensuring compliance with safety regulations.

Companies must implement a strategy to upgrade from Windows 10 to Windows 11 and ensure compliance with essential safety principles, including notifying customers about potential vulnerabilities.