G. If the resubmission is complete:1. Ensure the review clock...

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]
H. Continue review according to SOPP 8401: Administrative Processing of
Original Biologics License Applications (BLA) and New Drug Applications
(NDA) or SOPP 8401.2: Administrative Processing of BLA and NDA
Supplements. [Review Committee Members] NOTE: A review of the filing
checklists is recommended to ensure review continuity and completeness,
particularly for files that may have been in CR status for an extended period.