Elite Pharmaceuticals Inc (ELTP)

[Couch]

MAPPING OUT THE TIMING OF A COMPLETE RESPONSE SUBMISSION

http://camargopharma.com/2015/02/mapping-out-the-timing-of-a-complete-response-submission/

The process described in the MAPP is pretty straightforward:

Applicant submits a response to a Complete Response Letter (CRL)

FDA determines whether or not the response is complete and responds in a letter to the applicant within 30 calendar days

If FDA determines the response is NOT complete CDER so informs the applicant and the review clock does not start until a complete response is received.

If FDA determines that the response is complete, it will be classified as Class 1 or Class 2
If the CRL is classified as a Class 1, CDER will complete the review and act on the application within 2 months of the receipt date

A Class 1 classification includes

Final printed labeling
Draft labeling
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)
Stability updates to support provisional or final dating periods
Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
Assay validation data
Final release testing on the last 1 to 2 lots used to support approval
A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)
Other minor clarifying information (determined by CDER as fitting the Class 1 category)
If the CRL is classified as a Class 2, CDER will complete the review and act on the application within 6 months of the receipt date

A Class 2 resubmission includes any item not specified as a Class 1 item, including any item that would require a presentation to an advisory committee. A resubmission that requires a reinspection also would be a Class 2 resubmission.