Study: Price, therapeutic value impact international submission times for new drugs
Regulatory NewsJeff Craven
AsiaBiologics/ biosimilars/ vaccinesEuropeEuropean Medicines Agency (EMA)Health CanadaOceaniaPharmaceuticalsPharmaceuticals and Medical Devices Agency (PMDA)Product LifecycleSubmission and registrationTherapeutic Goods AdministrationUnited StatesUS Food and Drug Administration (FDA)