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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