Moad,
It is possible but usually this is discussed in your pre-NDA meeting and there is a timeframe for submission. Per PDUFA :
The FDA and the applicant will agree on the content of a complete application for the proposed indication(s) at the pre-submission meeting. The FDA and the applicant may also reach agreement on submission of a limited number of application components not later than 30 calendar days after the submission of the original application. These submissions must be of a type that would not be expected to materially impact the ability of the review team to begin its review. These agreements will be summarized at the conclusion of the meeting and reflected in the FDA meeting minutes. i. Examples of application components that may be appropriate for delayed submission include updated stability data (e.g., 15-month data to update 12-month data submitted with the original submission) or the final audited report of a preclinical study (e.g., carcinogenicity) where the final draft report is submitted with the original application. ii. Major components of the application (e.g., the complete study report of a Phase 3 clinical trial or the full study report of required long-term safety data) are expected to be submitted with the original application and are not subject to agreement for late submission.
If you are beyond this point, best to talk with your project manager to see what the implications may be.
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Robert Blanks RAC
VP, Regulatory Affairs and Quality Assurance
[Ardelyx]
Auburndale MA
United States
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Original Message:
Sent: 22-Aug-2023 02:18
From: Moad Esa
Subject: Additional stability data during review of NDA
Dear all,
I am trying to explore if it is possible to submit additional stability data for an NDA during the review process by FDA?
Are there any risks to consider?
Will this cause any delays?
Background: The product is freeze-dried vial + diluent vial. We seek to submit stability data with additional diluent that can be used for reconstitution of the freeze-dried vial.
Thank you!
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Moad Esa, M.Sc.
Regulatory Affairs Manager
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