Industry recommends that the Agency specify a standard format for applicants to use when submitting data sets. FDA should select appropriate software tools for reviewers based on these standards. Applicants should not be required to submit data in multiple file formats. Since this document also applies to amendments, supplements and safety updates, it would be useful to have naming conventions for these types of submissions as well. This allows a minimum number of files for the electronic archive, but may not be well suited to the needs of the reviewer.
Recent experience suggests that reviewers often navigate the contents to a desired table or figure.
In the proposed model, this is not possible. The reviewer would be required to open a relatively large file, locate the desired file in the TOC, and then use a hyperlink to move to the table. In addition, it is difficult to have multiple viewing applications open concurrently, as is often the practice when reviewing a study report and appended tables. Industry recommends allowing the review division to negotiate how of study report components are packaged with sponsors to meet reviewer needs. There are times when animals are used in multiple studies.