24 July 2012
THE eCTD SUMMIT: Are you Ready for the 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 electronic submission 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.
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