FDA temporarily retreating on impurities for market shortage

FDA temporarily raising tolerance on impurities due to market shortage

FDA has issued setting temporary rules on a probable cancer-causing impurity formerly regulated. To avoid market shortage of Losartan, drugmakers will be able to make losartan with an impurity percentage above its prescribed level for six months while the supply of clean drugs is ramped up. A calculated risk, to preserve blood pressure drugs availability […]

EMA 2025 Regulatory Strategy Shaping Future Public consultation human stakeholders workshop

EMA 2025 Regulatory Strategy

European Medicines Agency (EMA), has published its draft of ‘Regulatory Science to 2025’ strategy for a six-month public consultation, following the workshop organized last October. This “Reflection Paper” is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy will […]

Gilda D’Incerti at CoE for the Second International Week on Regulatory Affairs

The Federal Commission for the Protection against Sanitary Risks in Mexico (Comision Federal para la Proteccion contra Riesgos Sanitarios or COFEPRIS) is pleased to announce the launch of the Second International Week on Regulatory Science and Good Regulatory Practices, organized by the Center of Excellence in Regulatory Science and Good Regulatory Practices (CoE) in collaboration […]