This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.
View this resource Bookmark this resource
FDA Qualification process – Drug Development Tools
Published by IRDiRC
Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpointBiomarkerAnimal ModelQualification ProcessDrug Development ToolCenter for Drug Evaluation and Research