GDUFA II Training - Performance Goals, Vince Sansone
GDUFA II Training IR and DR Letters, Michael Folkendt
GDUFA II Training - DMF Update, Erin Skoda
GDUFA II Training - Pre ANDA Program Pre Submission Meetings, Robert Lionberger
GDUFA II Training - Pre ANDA Product Development Meetings, Robert Lionberger
GDUFA II Training Review Status Updates, Dawn Kimble-Vance
GDUFA II Training - Post Complete Response Letter Meeting Request, Anh Bui
GDUFA II Training - Requests for Reconsideration at the Division Level under GDUFA, Priya Shah
GDUFA II Training - Goals Integration, Ted Sherwood
GDUFA
Features of GDUFA II
GDUFA III MCRM External Training Presentation final
GDUFA II Pre-ANDA Program Meetings: Advice for Success (10of27) Generic Drugs Forum 2018
Drug Master Files from a GDUFA II User Fee Perspective
GDUFA II – Review Timelines (14of27) Generic Drugs Forum 2018
GDUFA II (9/28) Generic Drugs Forum 2017
Introduction: About GDUFA
Completeness Assessments (CAs): Status, KASA for CA, Common Issues & GDUFA Commitment Letter Stats
GDUFA II User Fees: Update on Year One (21of27) Generic Drugs Forum 2018
Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017
