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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: Ron Nairn who wrote (8091)11/23/2001 9:59:44 AM
From: shakedown  Read Replies (5) | Respond to of 14101
 
Rondo,

I found this link on the FDA site which shows that the Pre-Approval Inspection (PAI) as one of the last steps in the NDA approval process.

The flow chart seems to indicate that labeling is discussed concurrently.

And as you have indicated this flow chart shows that a PAI will only occur if an approvable decision of "yes" is made on the filed material. "click on the review complete and acceptable box"

fda.gov

Warren


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