Introduction to Electronic Regulatory Submissions in the eCTD Format-April 2018

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Advanced therapies/cell and gene therapyAPIsBiologics/ biosimilars/ vaccinesBiotechnologyCombination products/companion diagnosticsCosmeticsDiagnostics/IVDsDigital health/SaMD/AIGenericsMedical DevicesNutritional/Natural HealthOTCOtherPharmaceuticals