Major Issues And Facilities In Drug Master Files Global Quality

Major Issues and Facilities in Drug Master Files (9/15) Global Quality

U.S. Food and Drug Administration

Introduction to the Drug Master File (DMF) Review Process

U.S. Food and Drug Administration

Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Review of Secondary Type II Drug Master Files

U.S. Food and Drug Administration

Questions and Answers on Drug Master Files (DMFs) and Drug Substances Part I

U.S. Food and Drug Administration

Timely Consult and Early Information Request (TCIR) Process for Drug Master Files (DMFs)

U.S. Food and Drug Administration

Effective Communication Strategies for Drug Master Files (DMF)

U.S. Food and Drug Administration

Drug Substance Facilities – Hidden and Critical Intermediate

U.S. Food and Drug Administration

Panel Discussion - Drug Master File and Drug Substance Workshop

U.S. Food and Drug Administration

What is a DMF (drug master file)?

Fernanda Waechter

Drug Master Files from a GDUFA II User Fee Perspective

U.S. Food and Drug Administration

Metrics on Drug Master File (DMF) Assessments

U.S. Food and Drug Administration

Panel Discussion – Drug Master File and Drug Substance Workshop

U.S. Food and Drug Administration

List of Relevant Quality Guidances & Common Deficiencies Observed during DMF Review

U.S. Food and Drug Administration

Panel Discussion – Drug Master File and Drug Substance Workshop

U.S. Food and Drug Administration

Administrative Aspects of Managing a Drug Master File (DMF)

U.S. Food and Drug Administration

Panel Discussion – Drug Master File and Drug Substance Workshop

U.S. Food and Drug Administration

Common Issues Related to LC and GC Methods in Type II DMFs

U.S. Food and Drug Administration

Keynote from Director Lawrence Yu - Drug Master File (DMF) and Drug Substance Workshop

U.S. Food and Drug Administration

API Manufacturing Global Distribution and Facility Profile Analysis

U.S. Food and Drug Administration