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They will need to repeat the study for sure
They will need to prove the combination has the same or better effect
Hi my name is ***** ***** I am happy to assist you. I have assisted many companies with getting FDA approvals and classifications. If they are using the same study that has already need approved they do not need to repeat this. Both medications are already approved all you will need to do is add this to the current study that has the approval. You will need to send in the reports of how your are combining the 2 medications. So all they need to do is use the same study and send in that report.
If it is a new diagnosis, then I'm sure a new study has to be done
Hi just checking in to see if you still need further assistance ?