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 Product Management Service and SPOR Literacy Can Strengthen a PV Career
EMA’s substance and product data management services guidance says marketing authorisation holders should verify that data submitted to XEVMPD or SIAMED...
Why AEMS Signals a More Connected Future for Digital Pharmacovigilance
FDA says its new Adverse Event Monitoring System, or AEMS, is designed as a centralized platform not just for adverse event reports, but also for consumer...
CVMP March 2026 Meeting Highlights Keep Veterinary Safety on the Radar
EMA published meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) for 10–12 March 2026. The agency says the meeting was followed by...
EMA Pushes ESMP Training as Shortage Reporting Matures
EMA’s “What’s new” page lists a new event for European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry dated 20...
Why MHRA’s 30-Day Type II Safety Variation Route Matters
MHRA’s variations guidance says a reduced Type II procedure, shortened from 60 days to 30 days, is available for variations concerning safety issues when...
What MHRA’s February 2026 Safety Roundup Signals for Drug Safety Teams
MHRA’s Safety Roundup: February 2026 describes itself as a summary of the latest safety advice for medicines and medical device users. The roundup highlights...
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...