Issue Date: May 1, 2021
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Final
Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals
The purpose of this document is to provides detailed information and specifications for the content of datasets that should be submitted as part of the sponsor’s or applicant’s application for drugs that are assessed for their evaluation of rodent carcinogenicity studies of pharmaceuticals in nonclinical studies. These specifications also provide an opportunity for dialogue between the sponsor or applicant and reviewers to discuss issues with trial design or study conduct that may affect the content of the analysis datasets. These specifications were built to support the data standards and processes described in the FDA Study Data Technical Conformance Guide and guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data.
Download the Guidance Document
