F. If the resubmission is incomplete:
1. Ensure the designation in the regulatory system is corrected to
“Incomplete Response to CR letter” if the review team confirms that the
submission did not address all issues identified in the CR letter. [RPM]
a. The data entry in the regulatory system should reflect receipt of an
Incomplete Response to CR letter rather than a complete response.
b. When the information in the system is corrected, the review clock is
re-set to reflect the original action close date.
2. Notify the applicant within 14 calendar days if the submission is
determined to be an incomplete response via email or telephone. [RPM]
3. Ensure all communications are documented in the appropriate regulatory
system and uploaded through CBER Connect.
Should that say we are pretty safe from any bad news?
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-542
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