Elite Pharmaceuticals Inc (ELTP)

[ARbigguy1]

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.