Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States
Carolina Iglesias-López, Mercè Obach, Antonio Vallano, Antònia Agustí
Topics & Concepts
AuthorizationMarketing authorizationEuropean unionDrug approvalOrphan drugMedicineEuropean marketBusinessInternational tradePharmacologyBioinformaticsBiologyComputer securityDrugComputer scienceBiomedical Ethics and RegulationHealth Systems, Economic Evaluations, Quality of LifeCAR-T cell therapy research