All portions of the applications should be submitted not later than one year after the initial submission. The applicant should obtain preliminary Agency agreement on the rolling application submission right before or at the pre-application meeting with products with breakthrough or fast track designation. A request for submission of rolling review should be sent as an amendment to the IND file including your expected timeline for complete module submissions and any late components, if needed. The review team will review and the Agency issue a letter communicating the decision to either grant or deny the rolling review request. If the fast track or breakthrough designations is rescinded, submission of portions of the applications will not be permitted. I hope this helps.
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Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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Original Message:
Sent: 26-Apr-2023 20:21
From: Anonymous Member
Subject: Rolling review
This message was posted by a user wishing to remain anonymous
For a rolling submission plan, what is the longest amount of time FDA will allow between first and last Module in for a NDA/BLA?
Thank you!