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...
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...
FDA Requests Removal of Suicidal Ideation Warning From Certain GLP-1 Labels
FDA says it is requesting that drug application holders remove information regarding suicidal ideation and behavior from the labeling of Saxenda, Wegovy, and...
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...
FDA’s Action on Xylazine Imports Shows How Safety Oversight Extends Beyond Approved Drugs
FDA announced action to restrict unlawful imports of xylazine active pharmaceutical ingredients and finished dosage-form drug products into the United States....
PRAC Reviewed 140 PSUR Recommendations in January 2026: What That Tells Us
EMA’s January 2026 PRAC statistics show 140 PSUR recommendations, along with reviews of risk management plans and study protocols and results. That is a...
Why EMA’s MSSG Matters When Shortages Become Safety Issues
EMA says the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) was established under Regulation 2022/123 and is responsible for...
CTIS Sponsor Training in June 2026 Signals the Growing Importance of Trial-System Skills
EMA has scheduled a CTIS sponsor end-user training programme for 8–11 June 2026. The event listing places the training firmly within the live operational...
EMA’s PMS FAQs Show Where Product Data Friction Still Exists
EMA’s Product Management Service FAQs, updated in January 2026, collect questions raised during PMS events and are intended to complement those sessions. EMA...
MHRA’s National Assessment Procedure Update: Why It Matters in 2026
MHRA updated its National assessment procedure for medicines guidance on 24 February 2026, setting out the agency’s UK national route for marketing...