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FDA Requests Removal of Suicidal Ideation Warning From Certain GLP-1 Labels
FDA says its review did not identify an increased risk of suicidal ideation or behavior with certain GLP-1 receptor agonists and is requesting label updates.
Today in PV
A quick scan of the latest stories, safety concerns, regulatory developments, and industry signals every pharmacovigilance professional should know today.
Explore Coverage
Browse the key areas shaping pharmacovigilance today, from global regulatory updates to safety signals, compliance trends, AI, and career growth.
Regulatory Updates
Track key developments from FDA, EMA, MHRA, WHO, NAFDAC, Health Canada, TGA, SAHPRA, and other health authorities.
Inspections & Compliance
Stay current on inspection readiness, CAPAs, SOP expectations, audit trends, and the compliance issues shaping PV systems.
Explainers
Clear, practical breakdowns of PV concepts, industry terms, reporting frameworks, and regulatory changes.
Careers
Insights for professionals building or advancing careers in pharmacovigilance, drug safety, compliance, and related functions.
Safety Signals
Follow emerging risks, label changes, recalls, medication errors, and other safety issues that matter in real-world pharmacovigilance.
AI & Digital PV
Explore how artificial intelligence, automation, and digital tools are influencing case processing, signal detection, and safety operations.
Latest News
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What the New AEMS Signal Page Means for Safety Intelligence Teams
FDA’s new AEMS signal page makes the agency’s potential-signal reporting process more visible and gives safety teams another reason to watch external intelligence closely.
Why AEMS Signals a More Connected Future for Digital Pharmacovigilance
FDA’s new AEMS platform points toward a broader model of digital safety surveillance, where adverse event reports sit alongside other important safety-related information streams.
How FDA’s Good AI Practice Principles Translate to Real PV Workflows
FDA’s 2026 Good AI Practice principles were written for drug development broadly, but they map directly onto pharmacovigilance workflows where context of use, oversight, and documentation matter.
Why EudraVigilance and E2B(R3) Skills Still Matter in 2026
In a year full of AI talk, EMA’s training agenda is a useful reminder that foundational reporting skills like EudraVigilance use and E2B(R3) literacy still matter.
Why AI Governance Is Becoming a Career Advantage in Pharmacovigilance
As AI spreads through regulated workflows, pharmacovigilance professionals who understand governance, documentation, and context of use may become more valuable than those who only know the tools.
Why EudraVigilance Training Is a Compliance Control, Not Just Admin
EMA’s approach to EudraVigilance training makes an important point: in regulated PV systems, user competence is part of compliance, not just onboarding.
Featured Posts
UK Clinical Trial Rules Change on 28 April 2026: What PV Teams Should Prepare For
Updated UK clinical trial regulations take effect on 28 April 2026. Here’s what pharmacovigilance and sponsor teams should know now.
FDA Launches AEMS: Why the New Adverse Event Monitoring System Matters for Pharmacovigilance
The FDA has launched the Adverse Event Monitoring System (AEMS), a new unified platform for adverse event reporting and analysis. Here’s what it means for pharmacovigilance professionals.
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