Academic Research INDs to Follow CTD Format: FDA Guidance
[Thursday, March 12, 2020]
Research INDs, sponsored mostly by academic centers, are exempt from electronic submission and, hence, are mostly filed in traditional paper format. FDA now wants even those INDs to follow the Common Technical Document (CTD) format and submit electronically via the Electronic Submission Gateway (ESG) but would exempt them from the electronic CTD requirements, namely the need for the XML backbone. FDA released a guidance document this week describing essentially the same requirements as those for commercial INDs for research INDs. The sponsors of research INDs are asked to follow the CTD format, and the same structure and granularity. The sponsors should simply organize their documents into folder per the CTD structure and upload them on the ESG. The ESG would accept the research INDs without the XML structure required for the commercial INDs. In short, FDA wants all INDs to be submitted electronically, whether or not they contain the XML backbone. Additionally, FDA wants all sponsors to follow CTD guidelines for organizing the content. Research INDs form a significant proportion of IND applications submitted to the FDA and because they follow the older IND format, versus the new CTD format, it seems they hinder FDA’s project management functions. Having reviewers get applications in the same CTD format could help with the review timelines and project management. However, for most academic sponsors, it would mean additional work and a learning curve so it might face some resistance. Also, if a sponsor is going to do the hard work to rearrange the IND application into the CTD format, it is easier to later nudge them to take one additional step to file the electronic CTD. Perhaps that’s the plan; to slowly get all IND applications in the eCTD format, even the ones exempt by law to do so.