PV Bulletin

Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Drug safety and regulatory intelligence for QPPV, Signal, Labeling, PV Ops, and Device Vigilance — daily briefings with operational next steps.

Latest intelligence

publicFDA · USA · Updated Jun 5, 2026

GE HealthCare Carestation Devices - Correction for Ineffective Ventilation in VCV Mode (FDA Class I Recall)

Urgency: High

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall / Correction
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publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

EMA Updates Acceptable Intake Levels for Nitrosamine Impurities in Human Medicines

Urgency: High

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.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Regulatory Update
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 5, 2026

Cosyland Kids Kitchen Step Stools recalled due to fall and entrapment hazards (Model CS0003)

Urgency: High

Immediately stop using the recalled stools, store away from children, and contact Wan Yi (866-677-3889 / customerservice-ca@cosyland.com) to request free repair parts (protective nets, stabilizing feet, instructions).

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Consumer product recall
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

Ixchiq (Chikungunya vaccine (live)) - Safety measures following PRAC review

Urgency: High

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

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: PRAC recommendation
Read impact briefarrow_forward
publicTGA · Australia · Updated Jun 5, 2026

TGA Safety Alert: FluMist Indicated Age Range Errors

Urgency: High

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

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 4, 2026

Wyze Solar Cam Pan Recalled Due to Burn and Fire Hazards

Urgency: High

Immediately stop use; visit Wyze Labs website for refund process. Report incidents to Health Canada.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Consumer product recall
Read impact briefarrow_forward
publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 4, 2026

Recall: Nature's Own Glucosamine Sulfate with Chondroitin and Magnesium Glycinate 1150mg

Urgency: High

Stop using affected batches; return to place of purchase for full refund.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Recall
Read impact briefarrow_forward
publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 4, 2026

Pharmatech MK-677 Capsules: Undisclosed Anabolic Steroid Found

Urgency: High

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

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward

Showing 25-32 of 103 updates