The year 2025 witnessed significant regulatory actions affecting the safety profiles of multiple gastrointestinal drug classes. From the persistent concerns surrounding PPIs and the emerging risks of GLP-1 receptor agonists, to the serious gastrointestinal toxicities of CAR-T therapy and the cardiac risks of loperamide overuse, the regulatory landscape for GI drugs continues to...
Drug Safety Update on Nasal Decongestants and a Local Case Report on Colistimethate-Induced Neurotoxicity
To separate signal from noise, the Uppsala Monitoring Centre (UMC) developed VigiGrade—a tool that assigns a completeness score to every single ICSR.
Most pharmacovigilance (PV) teams obsess over the seven-day and fifteen-day reporting deadlines, yet they overlook a far more insidious window—the first 48 hours after safety information reaches the company. This is the triage gap: a seemingly administrative interlude during which the clock-start date (Day 0) for expedited Individual Case Safety Reports (ICSRs) is...
Regulatory update on isotretinoin prescribing requirements, a detailed local case safety report documenting posterior reversible encephalopathy syndrome (PRES) in two pediatric oncology patients receiving cyclophosphamide-containing chemotherapy.
10 Fundamental patient rights essential for mitigating risks and preventing harm in healthcare settings.
Three persistent myths continue to shape how pharmaceutical companies, biotechs, and even some regulators approach pharmacovigilance (PV), and each one carries a multi-million-dollar price tag.
Advancing Medication Safety Through Knowledge and Vigilance
