NDA and BLA Resubmission Review Timelines Outlined in Revised MaPP
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 […]