PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
Industry Alert: Rising Scrutiny Over Proxy Interviews, False Representation, and Intermediary Misconduct in Pharmacovigilance Hiring
A growing wave of concern is emerging across parts of the pharmaceutical and drug safety industry over alleged proxy interviews, false professional...
How FDA’s Good AI Practice Principles Translate to Real PV Workflows
FDA’s January 2026 “Guiding Principles of Good AI Practice in Drug Development” lays out ten expectations for regulated AI, including human-centric design, a...
MHRA Approves Deuruxolitinib for Severe Alopecia Areata
MHRA announced on 12 March 2026 that it approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults. The agency also stated that, as with any...
FDA Requests Removal of Suicidal Ideation Warning From GLP-1 Labels
FDA says it is requesting that drug application holders remove information regarding suicidal ideation and behavior from the labeling of certain GLP-1...
A Missing Safety Warning in a PIL Became a Bigger GPvP Lesson
MHRA’s December 2025 Class 4 Medicines Defect Notification for certain amitriptyline tablets says the patient information leaflet contained out-of-date safety...
Why XEVMPD Knowledge Still Matters for Modern PV Professionals
EMA says the eXtended EudraVigilance Medicinal Product Dictionary, or XEVMPD, supports pharmacovigilance activities in the EU, and it continues to publish...
Why E2B(R3) and EVWEB Skills Still Open Doors in 2026
EMA’s 2026 hands-on EudraVigilance training says participants should be able to apply ISO/ICH E2B(R3) rules to spontaneous and follow-up reports, amendment...
Why AI Governance Is Becoming a Differentiator in PV Careers
FDA’s 2026 Good AI Practice principles emphasize context of use, multidisciplinary expertise, data governance, lifecycle management, and clear essential...
A Missing PIL Warning, a GPvP Inspection, and a Bigger Compliance Lesson
MHRA’s December 2025 defect notification for certain amitriptyline tablets says the patient information leaflet did not contain all required safety...
Why EudraVigilance Training Is a Compliance Requirement in Practice
EMA says it provides EudraVigilance training to support stakeholders in meeting their pharmacovigilance obligations and to ensure users understand system...