FDA resubmittal for SequestOX 2 month review.
Here is the process - probably will be a Class 1.
The review team and division director will determine whether the resubmission constitutes a complete response that addresses all deficiencies in the complete response letter. If so, the review team and the division director will classify the resubmission as Class 1 or Class 2.2
? The regulatory project manager will issue a letter to the applicant within 30 calendar days, acknowledging receipt of the resubmission.
? If CDER does not agree that the submission is a complete response addressing all deficiencies in the complete response letter, CDER will inform the applicant in the letter and the review clock will not start until a complete response is received.
? If CDER agrees the submission constitutes a complete response, the letter will state the classification and provide the due date for action.
? CDER will complete the review and act on Class 1 resubmissions within 2 months of the receipt date.
Class 1 Resubmission — A resubmission that includes one or more of the following items:
1. Final printed labeling
2. Draft labeling
3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences, not previously reported with the product are presented in the resubmission)
4. Stability updates to support provisional or final dating periods
5. Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
6. Assay validation data
7. Final release testing on the last 1 to 2 lots used to support approval
8. A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)
9. Other minor clarifying information (determined by CDER as fitting the Class 1 category)
