GUIDELINE FOR DRUG MASTER FILES

Center for Drug Evaluation and Research

Food and Drug Administration
Department of Health and Human Services
September 1989
TABLE OF CONTENTS
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
A. Transmittal Letters
1. Original Submissions
2. Amendments
B. Administrative Information
1. Original Submissions
2. Amendments
C. Drug Master File Contents
1. Types of Drug Master Files