FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational product.
FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.
FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational product.
FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.
FDA approves Ionis Pharmaceuticals’ Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients.
A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled devices.
