GUIDANCE DOCUMENT
Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals May 2021
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.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.