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.
Urgency: high

Latest intelligence

publicUK Health Security Agency · UK · Updated Aug 27, 2026

UK Salmonella Outbreak Linked to Imported Eggs

Urgency: High

Implement enhanced surveillance and tracking of Salmonella cases linked to imported eggs, potentially increasing ICSR submissions related to these infections.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicUK Health Security Agency · UK · Updated Aug 27, 2026

Vaccination Guidance to Improve Childhood Immunization Rates

Urgency: High

Parents are encouraged to ensure their children receive timely vaccinations according to the NHS schedule to increase overall immunization rates and adherence to WHO guidelines.

Country ComplianceMedical Safety Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Medical Safety Lead
verifiedRegulatory action: Regulators
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publicFDA · USA · Updated Aug 27, 2026

FDA Prohibits Use of Dietary Supplement Grade Glutathione in Injectables

Urgency: High

Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 27, 2026

FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults

Urgency: High

Update product labeling to include Lisraya as the first oral treatment for dermatomyositis, ensuring that all marketing and educational materials reflect its approval and associated safety information.

LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Latest
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publicFDA · USA · Updated Aug 26, 2026

Approval of Multiple Oncology Products by FDA

Urgency: High

Review and update internal compliance and reporting workflows to align with the FDA's reporting requirements for the latest oncology product approvals.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicFDA · USA · Updated Aug 27, 2026

FDA Issues Emergency Use Authorization for Bimectin Injection to Prevent New World Screwworm in Cattle

Urgency: High

Cattle producers must administer Bimectin injection within specified timelines (24 hours post-birth, at castration, or on wound appearance) and observe a 35-day withdrawal period before slaughter to prevent drug residues in food.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicFDA · USA · Updated Aug 27, 2026

AVID Medical Correction for Convenience Kits Containing Medline Namic Star Off Handle Manifolds

Urgency: High

All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Devices
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publicFDA · USA · Updated Aug 27, 2026

Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging

Urgency: High

Customers must immediately identify and quarantine all unused affected devices (Bravo CF capsule delivery devices, product numbers FGS-0635 and FGS-0636) and return them to Medtronic for replacement.

Signal ManagementInspection ReadinessQPPV
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward