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...
FDA’s 10 Good AI Practice Principles: What They Mean for PV Teams
The FDA’s Guiding Principles of Good AI Practice in Drug Development, published on 14 January 2026, may not have been written specifically for...
FDA Requires Vitamin B6 Deficiency Warning for Carbidopa/Levodopa
FDA says it is requiring application holders for all drug products containing carbidopa/levodopa to add a warning that these medicines can cause vitamin B6...
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...
What the Amended CIR 520/2012 Means for Some UK-Authorised Products
MHRA says that amendments to the EU Commission Implementing Regulation 520/2012 took effect on 12 February 2026 and, although the UK operates an independent...
Why MedWatch Still Matters in the Age of Digital Safety Platforms
FDA says MedWatch is its program for reporting serious reactions, product quality problems, therapeutic inequivalence or failure, and product-use errors for...
What the New AEMS Signal Page Means for Safety Intelligence Teams
FDA says that when a potential signal of a serious risk is identified from AEMS data, it will be posted in the required quarterly report in the quarter in...
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...
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...
Why EudraVigilance and E2B(R3) Skills Still Matter in 2026
It is easy to assume that modern pharmacovigilance careers are moving entirely toward AI, automation, and advanced analytics. But EMA’s 2026 EudraVigilance...