Gdufa

GDUFA

U.S. Food and Drug Administration

Introduction: About GDUFA

U.S. Food and Drug Administration

GDUFA I Accomplishments

U.S. Food and Drug Administration

GDUFA III: Facility Readiness

U.S. Food and Drug Administration

Part-1 GDUFA l Generic Drug User Fee Act l FDA l Regulatory Affairs l #pharmaceutical#regulations

GDUFA III: Controlled Correspondence

U.S. Food and Drug Administration

Part-2 GDUFA lll updates l Generic Drug User Fee Act l FDA l Regulatory Affairs l #pharmaceuticals

GDUFA II Training IR and DR Letters, Michael Folkendt

U.S. Food and Drug Administration

GDUFA II Training - Pre ANDA Product Development Meetings, Robert Lionberger

U.S. Food and Drug Administration

GDUFA III Goal Date Illustrations

U.S. Food and Drug Administration

Update on GDUFA Science and Research

U.S. Food and Drug Administration

A Deep Dive: GDUFA III Scientific Meetings

U.S. Food and Drug Administration

GDUFA II Training - Performance Goals, Vince Sansone

U.S. Food and Drug Administration

GDUFA/BsUFA User Fees Explained

Association for Accessible Medicines

GDUFA II Training - DMF Update, Erin Skoda

U.S. Food and Drug Administration

GDUFA II Training - Pre ANDA Program Pre Submission Meetings, Robert Lionberger

U.S. Food and Drug Administration

Completeness Assessments (CAs): Status, KASA for CA, Common Issues & GDUFA Commitment Letter Stats

U.S. Food and Drug Administration

GDUFA III MCRM External Training Presentation final

U.S. Food and Drug Administration

GDUFA II (9/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Keynote and Session 1

U.S. Food and Drug Administration