FDA guidance outlines where to send “cross-center” master files
Regulatory NewsJoanne S. Eglovitch
Biologics/ biosimilars/ vaccinesCBERCDERCDRHChemistry, Manufacturing and Controls (CMC)Combination productsDrug master file (DMF)ExcipientsManufacturingMedical DevicesPharmaceuticalsProduct developmentSupply Chain ManagementUnited StatesUS Food and Drug Administration (FDA)