Review Checklist for NDAs

  • Introduction

  • General issues

  • Organizing the main folder

  • Organizing the electronic submission

A. Item 1: table of contents (Index)

B. Item 2: labeling

C. Item 3: summary

D. Item 4: chemistry, manufacturing, and control (CMC)

E. Item 5: nonclinical pharmacology and toxicology

F. Item 6: human pharmacology and bioavailability/bioequivalence

G. Item 7: clinical microbiology

H. Item 8: clinical

 I. Item 9: safety update

J. Item 10: statistical

K. Item 11: case report tabulations (crts)

L. Item 12: case report forms

M. Item 13: patent information

N. Item 14: patent certification

O. Item 15: establishment description (CBER only)

P. Item 16: debarment certification

Q. Item 17: field copy certification

R. Item 18: user fee cover sheet

S. Item 19: other