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To: Mark Bartlett who wrote (8674)2/7/2002 10:29:11 PM
From: Montana Wildhack  Respond to of 14101
 
Mark,

I can't imagine what the not-high-quality submissions
might be going through.



To: Mark Bartlett who wrote (8674)2/7/2002 10:37:16 PM
From: Joe Krupa  Respond to of 14101
 
Hi Mark,

Thanks for that find. That helps the understanding of the process a bit.

"The TPD aims not to issue very many NODs (Notice of Deficiency, which stops the review process) but to rely on clarifaxes and NON (does not stop the review process) to address deficiencies in high quality submissions"

Given that the NON (Notice of Non-Compliance) is a process in which HC appears to clarify certain points in a NDS, it seems like a perfect process to invoke to buy some time until FDA pronounces. It's almost like somebody at HC started flipping through the NDS process to see which throw back they could pull out of the hat to stall the final decision, just enough to let FDA have the floor first.

Again, what a joke!

joe