Even if more than one ODD is granted, the sponsor needs to reapply at the time of marketing approval(s) and reconvince the regulatory authority that the diseases are still rare and that two formulations are different products.
So getting two marketing approvals with ODD isn't guaranteed upfront.
Even if more than one ODD is granted, the sponsor needs to...
-
- There are more pages in this discussion • 20 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
