It is negotiated at the pre-NDA meeting. The briefing document should propose a timeline. I have gotten 6 months in the past.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 17-Nov-2020 15:26
From: Anonymous Member
Subject: Rolling review submission timelines
This message was posted by a user wishing to remain anonymous
In a rolling review submission plan, is there a regulated (per guidance) time frame from the date of first submission to the date of last submission, or is this negotiable at pre-NDA meetings and/or rolling review requests?