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Posted On: 09/14/2020 2:45:36 PM
Post# of 72447
Sox- Looks like the link you posted from the FDA concerning the IND pre-meeting criteria was from 2009.
Here's the one related to Covid: https://www.fda.gov/media/137927/download
Hoping (praying) it's not a 4wk turnaround for a meeting-response currently.
I thought I saw somewhere that it was maybe faster.
Agreed, if meeting was granted, we would know...
Here's the one related to Covid: https://www.fda.gov/media/137927/download
Hoping (praying) it's not a 4wk turnaround for a meeting-response currently.
I thought I saw somewhere that it was maybe faster.
Quote:https://www.accessdata.fda.gov/cder/sb-naviga...3_0370.htm
(Generally, the earliest a meeting can be requested to be held is the day after the response goal; 14 days for Type A meetings and 21 days for Type B and C meetings.)
Agreed, if meeting was granted, we would know...
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