GDUFA III

0:08:01

GDUFA III: Controlled Correspondence

0:05:04

GDUFA III: Facility Readiness

1:30:14

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

0:11:19

GDUFA III MCRM External Training Presentation final

2:57:33

A Deep Dive: GDUFA III Scientific Meetings

0:11:50

ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA

1:19:35

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

0:03:12

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

1:29:48

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 4 and Closing Remarks

0:14:24

GDUFA III Goal Date Illustrations

2:26:13

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval

0:06:37

GDUFA II Training - Performance Goals, Vince Sansone

0:02:52

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

0:08:08

ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions

0:01:09

GDUFA I Accomplishments

0:05:37

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

0:05:53

GDUFA II Training IR and DR Letters, Michael Folkendt

0:00:14

fgygrrfyyhgffhhh huh uh HD set yh or f GB ji it yi kg DUI or et uh ji if fyi yi j yr t5 TCU i ji

1:40:10

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 2

0:02:11

Features of GDUFA II

0:17:19

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

0:00:59

GDUFA lll updates l Generic Drug User Fee Act l FDA l #pharma #regulatoryaffairs

0:03:27

Crushing Crunchy & Soft Things by Car! EXPERIMENT: Car vs Coca Cola, Fanta, Mirinda Balloons

0:20:23

Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017