Impact of the FDA’s eCTD Mandate
With the FDA Safety & Innovation Act now signed into law, life science companies will need to start thinking strategically about the impact of the FDA’s eCTD mandate and how to quickly and easily comply. Since most of the larger companies already submit electronically, the greatest impact will be to the smaller, virtual companies that do not have substantial IT infrastructure in place, and lack the overall budgetary flexibility of their larger peers.
One benefit for these smaller companies is that the FDA will provide 36 months for compliance for those companies that will submit original IND submissions and amendments after final guidance is provided, instead of 24 months for NDA and BLA submissions. With that being said, the time is now to prepare and plan for electronic submissions. Companies must decide the best avenue for compliance whether it is bringing publishing in-house, outsourcing, or utilizing a combination of the two.
If bringing publishing in-house, then you should look for a cloud computing solution which does not require large IT infrastructure investment but provides easy and secure access to state-of-the-art software. This can be a tremendous advantage for smaller companies dealing with budgetary constraints.
It may also be worthwhile to explore an intermediate option, where you purchase a software solution and begin publishing in-house while contracting with a partner firm to augment your staff should the submission work exceed your internal resources. This can be an economical option from a cost perspective too, plus, it provides your internal resources with valuable experience for future submissions and a manageable roadmap towards full in-house publishing.
Whatever option you chose, having a plan in place should provide you with peace of mind as the compliance date draws closer.