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Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

Identify affected lots and implement recall procedures as per Health Canada guidelines.

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.

Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.

1) Verify your internal signal assessment narrative for GLP-1 RAs reflects FDA’s statement that the preliminary evaluation does not suggest a causal link; 2) Check whether any company-facing statements, FAQs, or labeling change proposals referencing suicidality need to be updated for consistency with FDA’s current public position; 3) Log the FDA update in regulatory intelligence tracking and maintain monitoring for further FDA conclusions or requests (including the linked 13 Jan 2026 communication).

1) Map portfolio to MHRA’s Category 1 vs Category 2/NI MA status referenced in the Windsor Framework PV guidance; 2) Update PSUR submission SOPs/work-instructions and submission trackers to ensure Category 1 PSURs route via the MHRA PSUR portal and Category 2/NI MA PSURs route via the EU PSUR Repository (and confirm when no separate MHRA submission is needed); 3) Re-check related MHRA PV procedure guidance for any additional submission/documentation expectations impacting signals, RMPs and PASS.

Fda update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

This update requires triage for Signal Validation, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

Tga update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.

Mhra update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

This update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.

Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.

Review updated EMA guidance on mechanistic model reporting and qualification when published; align sponsor submissions with new qualification pathways and reporting requirements for MIDD and safety-related models.

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.

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.