The FDA published its second revision of “Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters,” MaPP 6020.4 today.
The FDA issues MaPPs to provide instruction to its internal staff on policy and procedure in dealing with various issues. The document identifies resubmissions to NDAs, BLAs, and efficacy supplements as either Class 1 or Class 2 submissions. Class 1 submissions are to be reviewed in two months and Class 2 submissions will be on a six-month review clock. The FDA notes that these goals for resubmission have been codified in 21 CFR 314.110.
The FDA gives examples of Class 1 resubmissions in the MaPP as follows:
- 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 post-marketing requirements/commitments, including proposals or protocols for such requirements/commitments
- Assay validation data
- Final release testing on the last one to two lots used to support approval
- A minor reanalysis 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)
All other types of resubmissions will be classified as Class 2.
The FDA also notes that resubmissions must be complete when submitted. Failure to do so will result in another communication to the sponsor to provide the missing information before the review clock begins. The full MaPP can be found here.
