CDER/FDA Formats for Submission of Animal Carcinogenicity Study Data

Abstract

The Center for Drug Evaluation and Research/Food and Drug Administration (CDER/ FDA) routinely requests that drug sponsors submit in their New Drug Applications’ carcinogenicity studies electronic data sets for its statistical reviewers to perform independent statistical analyses to evaluate sponsors’ analyses and conclusions. The recommended formats for submission of data are based on the information needs for such statistical analyses. Two sets of formats and specifications, that is, the Divisions of Biometrics Formats and Specifications and the Submitter Toxicological Uniform Data Information Exchange Standard (STUDIES) formats, are currently used by the Divisions of Biometrics. Sponsors can follow one of the two sets of formats and specifications in the preparation for data submission. The Divisions of Biometrics, however, strongly encourage sponsors to submit the data sets in the simpler Divisions of Biometrics formats and specifications. This paper includes a discussion on the methods of statistical analysis routinely used by FDA statisticians in their reviews, and listings of the CDER/FDA formats and specifications in the 3/12/97 official document (reference 12).