PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
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 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...
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. MHRA also notes that the medicine was...
MHRA and NICE Launch Faster Joint Approval Pathway
MHRA and NICE announced a streamlined approval process intended to help patients in England receive some new medicines three to six months earlier. The...
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...
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...
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...