Canda Submissions: A Retrospective Look at a Sponsor's Experience

Abstract

Computer assisted new drug applications (CANDAs) can be as simple as data submitted in electronic format such as ASCII files, or as complex and sophisticated as systems that enable the Food and Drug Administration (FDA) reviewer to access sponsor databases, case report form (CRF) images, listings, tables, and text. A CANDA application was submitted to the Division of Topical Drug Products of FDA for Loprox® Gel by Hoechst-Roussel Pharmaceuticals Inc. (now Hoechst Marion Roussel, Inc.) in December 1994. The software used for this submission, Integrated CANDA™ (ICANDA), was a data access, review, and reporting tool that enabled the FDA reviewer to access the clinical database, the CRF images, tables, and report text. The reviewer could create tables, listings, graphs, perform simple statistical analyses, and cut and paste from the generated output to his review document. The features of the software, contents of the submission, corresponding documention, validation, and advantages and disadvantages of this CANDA submission are presented.