How should I answer the questions with the optional file attachment in the FDA eSubmitter application?
The software is designed to allow you to enter a response in an executive summary format in the text box. The software then allows you to attach a file containing supporting information. The attached files can be study design, clinical protocols, raw data, SAS transportable files, Excel data sheets, etc. It is very important that you answer each question separately because the Reviewing software uses the information in the Executive Summary text box to generate the review memo and the Decision Summary that will be posted on the web page.
