GDUFA

GDUFA0:08:40

GDUFA

Introduction: About GDUFA0:02:50

Introduction: About GDUFA

GDUFA I Accomplishments0:01:09

GDUFA I Accomplishments

GDUFA III: Facility0:05:04

GDUFA III: Facility Readiness

Part-1 GDUFA l0:02:52

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

GDUFA III: Controlled0:08:01

GDUFA III: Controlled Correspondence

GDUFA II Training0:05:37

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

Part-2 GDUFA lll0:03:12

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

GDUFA III Goal0:14:24

GDUFA III Goal Date Illustrations

Update on GDUFA0:51:35

Update on GDUFA Science and Research

GDUFA II Training0:05:53

GDUFA II Training IR and DR Letters, Michael Folkendt

GDUFA/BsUFA User Fees0:02:42

GDUFA/BsUFA User Fees Explained

GDUFA III MCRM0:11:19

GDUFA III MCRM External Training Presentation final

GDUFA II Training0:06:37

GDUFA II Training - Performance Goals, Vince Sansone

A Deep Dive:2:57:33

A Deep Dive: GDUFA III Scientific Meetings

GDUFA II Training0:06:53

GDUFA II Training - DMF Update, Erin Skoda

GDUFA II (9/28)0:19:43

GDUFA II (9/28) Generic Drugs Forum 2017

DMF Workshop: GDUFA1:19:35

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

GDUFA II Training0:04:50

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

GDUFA II –0:17:19

GDUFA II – Review Timelines (14of27) Generic Drugs Forum 2018

Drug Master Files0:15:13

Drug Master Files from a GDUFA II User Fee Perspective

Public Comment -0:20:39

Public Comment - GDUFA Science and Research Initiatives Public Workshop

Completeness Assessments (CAs):0:18:58

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

DMF Workshop: GDUFA1:30:14

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 3