Posted On: 09/11/2013 3:39:58 PM
Post# of 5066
BMSN Ihell. Post. I posted info with link to FDA site many many months ago concerning the IND and Orphan drug status approval. On mobile so not easy to hunt it down...
It stated something like this...once an IND application is approved, the application package is automatically forwarded to the Orphan drug status review section for determining if it meets requirements to be awarded Orphan drug status designation.
Wondering if it has finished with the IND portion, possibly explaining why it is now visible on the FDA's site. Since while in IND status it is totally held in confidential status, including FDA unable to even acknowledge the application even exist on any thing in the IND process to anyone except designated company officials.
It stated something like this...once an IND application is approved, the application package is automatically forwarded to the Orphan drug status review section for determining if it meets requirements to be awarded Orphan drug status designation.
Wondering if it has finished with the IND portion, possibly explaining why it is now visible on the FDA's site. Since while in IND status it is totally held in confidential status, including FDA unable to even acknowledge the application even exist on any thing in the IND process to anyone except designated company officials.
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