EMA Addresses Early, Asymptomatic Alzheimer’s In ‘Hugely Important’ Clinical Study Guidance
The European Medicines Agency expects its revised guidance to facilitate the development of medicines to prevent and treat Alzheimer’s disease.
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The European Medicines Agency chief Guido Rasi is worried that if work on guidance development and revision stutters, "the whole system may suffer."
Outlook Therapeutics is hoping to secure EU marketing approval for the first ophthalmic formulation of bevacizumab.
Two new electronic catalogs of real-world data sources and studies offer an improved and more efficient service to help drug companies, regulators and researchers find adequate data sources to generate real-world evidence for regulatory purposes, says the European Medicines Agency.