How does the FDA use NCL data when an NCL collaborator submits an Investigational New Drug (IND) filing?
A. Data derived from the NCL assay cascade are intended to be included in an investigator-led filing of an Investigational New Drug (IND) with the FDA. Since the NCL sponsor initiates and files the IND, the sponsor decides if and how NCL data are presented to the FDA in the IND filing. NCL data alone, however, will not be sufficient to meet the FDA’s requirements for an IND. If the NCL’s assays predict favorable in vivo safety and efficacy, NCI and the NCL anticipate the sponsor will pursue the translation of the technology into clinical applications.
Related Questions
- Is the path to Food and Drug Administration (FDA)/Investigational New Drug ( IND ) clearance the same as that for other Australian biotechnology companies or global pharmaceutical companies?
- Which FDA office may an IRB contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?
- How does the FDA use NCL data when an NCL collaborator submits an Investigational New Drug (IND) filing?
