February 29, 2008                                                                                         Tips & Tricks - 022908

Did you know that the FDA has created a process allowing sponsors to test their understanding of eCTD prior to submitting their actual Drug application? The FDA Pilot program, created in 2005, was designed to allow sponsors to demonstrate their understanding of the eCTD and their ability to create a technically valid sample submission. The sample submission should be representative of the final eCTD dossier and should, at minimum, include navigational items for all modules. When compiling the Module 4 and 5 Study Report, the sponsor should also demonstrate their understanding of the study data specifications, e.g. study tagging files. Once submitted, the FDA will provide feedback regarding the technical compliance of the eCTD.