PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
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...
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...
FDA Approves Wegovy HD in 54 Days Under Priority Voucher Pilot
FDA announced on 19 March 2026 that it approved Wegovy HD (semaglutide 7.2 mg) for weight loss and long-term weight maintenance in certain adults. The agency...
What EMA’s 2026 Biologics Safety Page Signals About Ongoing Regulator Transparency
FDA’s 2026 Safety and Availability Communications page for biologics says it was developed to provide the public with important information about the safety...
MHRA Highlights Very Rare NAION Risk with Semaglutide
MHRA says non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden vision deterioration, has been very rarely reported in...
PRAC Updates Ixchiq Safety Warnings After Aseptic Meningitis Review
EMA’s Pharmacovigilance Risk Assessment Committee said it completed its review of a safety signal involving aseptic meningitis with Ixchiq, the live...
FDA Adds Earlier MRI Monitoring for Leqembi Patients
FDA has required an additional MRI between the 2nd and 3rd Leqembi infusions to help detect amyloid-related imaging abnormalities with edema, or ARIA-E,...
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...
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Class 4 Medicines Defect Notification for certain amitriptyline tablets says the patient information leaflet contained out-of-date safety...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...