Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAP Members-

Under PDUFA VI, does the NDA review clock for NME start at Day 60 rather than Day 0?  Under PDUFA V the "Program"  this was the case, but I am not sure if the "Program" was renewed under PDUFA VI.

As always, thank you so much for your advice!!

The "program" was created and has not been rescinded.  The attached guidance is from the current MAPP.

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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 06-Nov-2018 11:15
From: Anonymous Member
Subject: NDA Review Timelines

This message was posted by a user wishing to remain anonymous

Dear RAP Members-

Under PDUFA VI, does the NDA review clock for NME start at Day 60 rather than Day 0?  Under PDUFA V the "Program"  this was the case, but I am not sure if the "Program" was renewed under PDUFA VI.

As always, thank you so much for your advice!!