Regulatory Class - Parts of a NDA Annual Report

Question 1

Parts of a NDA Annual Report

Answer 1

FDA Form 2252
Summary
Distribution data
Authorized generic drugs (if applicable)
Labeling
CMC Changes
Nonclinical lab studies
Clinical data
Status reports of post marketing study commitments
Status of other postmarketing studies
Log of outstanding regulatory business

Question 2

Parts of a NDA Annual Report: Labeling

Answer 2

Current labeling

Summary of any changes in labeling

Question 3

Parts of a NDA Annual Report: CMC Changes

Answer 3

New reports

Full description of changes

Question 4

Parts of a NDA Annual Report: Clinical Data

Answer 4

Published clinical trials
Completed unpublished trials
Analysis of safety and efficacy in pediatrics

Question 5

Parts of a NDA Annual Report: Status reports of postmarketing study commitments

Answer 5

Content of reports

Public disclosure studies

Question 6

Parts of a NDA Annual Report: Status reports of postmarketing study commitments: Contents of reports

Answer 6

• Applicant name, product name, application number, date of approval, date of commitment, description of commitment, schedule
• Status: pending, ongoing, delayed, terminated, submitted
• Explanation of study status