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Posted On: 09/01/2020 1:51:10 AM
Post# of 148936
Doing some digging. I've read some documents that refer to "stop the clock" when an RTF is issued. While the Type A meeting is arranged, sponsor responses made, and FDA decisions made....the timeline is on hold.
So, my understanding is that since the original application is in FDA possession, there does not need to be a new submission and start over of the timeline. It should pick up where left off based on what RTF was issued for.
So, my understanding is that since the original application is in FDA possession, there does not need to be a new submission and start over of the timeline. It should pick up where left off based on what RTF was issued for.
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