Module 1 2021

Marketing Application - FDA Review

31

31

NDA/BLA Review Actions

• Refusal to File

− <60 days after submission

• Not Approvable letter − List deficiencies in application why product can not be approved based on current submission • Approvable letter − Signals that product ultimately can be approved. Lists minor outstanding deficiencies (i.e., label, Phase 4 commitments) • Approval letter

32

32

16