2023 The Final Countdown, page-35

Yes @reginaldp the CBER document pertaining to "resubmissions" confirms that Mesoblast should receive notification from them within 14 calendar days of either "resubmission is incomplete" or "resubmission is complete" .... as I have posted previously, I was not aware that Mesoblast would get another chance if this resubmission was deficient in some areas, but according to the official CBER document they do ?


14 calendar days has definitely passed in the USA now that it is 5:22pm in the east coast on Tuesday 14th February so I would envisage some sort of notification today ? GLTAH


https://www.fda.gov/media/84417/dow...within 2 months,considered a new review cycle.


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 of receipt if the submission is determined to be an incomplete response via letter (if issues are complex), email, or telephone. [RPM]

3. Ensure all communications are documented in the appropriate regulatory system and uploaded into CBER’s electronic repository (CER). [RPM]




G. If the resubmission is complete:

1. Ensure the review clock was started upon receipt once the review team confirms that the resubmission is complete and the designation of “Response to CR letter” is selected in the regulatory system. [RPM]

2. Determine initially whether the submission is a Class 1 or Class 2 Resubmission if the applicant indicates a complete response for a PDUFA application or efficacy supplement. Note: Class 1 or Class 2 designations do not apply to: manufacturing or labeling supplements, non-user fee or biosimilar biological products. [RPM]

3. Confirm Class 1 or Class 2 category if the resubmission responds completely to an action letter for a PDUFA application or efficacy supplement. [Review Committee Members]

4. Send a Resubmission Acknowledgement Letter for an original application or efficacy supplement within 14 calendar days of receipt, indicating the new goal date to the applicant. [RPM]

5. Acknowledge a resubmission for a labeling or manufacturing supplement by letter, telecon, or secure email within 14 calendar days, indicating the new goal date. [RPM]

6. Ensure all communications are documented in the appropriate regulatory system and uploaded into the CER. [RPM]