Submit to the FDA to seek approval? If so, was there any previous discussions with the FDA regarding the requirements for filing and approval of your proposed target indication? Lot of factors go into this decision. Was this an already marketed entity and going for an additional indication, or new entity/new indication, unmet medical need/Orphan indication, etc etc........Depending on all these factors, one can create en effective regulatory strategy to start discussion with the FDA (i.e. with an appropriate review division) to seek approval.
Hope this helps
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GRSAOnline
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Original Message:
Sent: 25-Apr-2018 13:34
From: Anonymous Member
Subject: Investigator Initiated Trials
This message was posted by a user wishing to remain anonymous
Hello,
Can you use data from Investigator Sponsored Trials and submit it to the FDA? For e.g. create a clinical study report (if you have access and agreement to use the investigator's data)?
What are some of the challenges you may expect or the limitations of such an approach?
Thanks,
Anon