GDUFA II Training IR and DR Letters, Michael Folkendt

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GDUFA II Training - DMF Update, Erin Skoda

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

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GDUFA II Training - Performance Goals, Vince Sansone

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GDUFA II (9/28) Generic Drugs Forum 2017

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Features of GDUFA II

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

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Drug Master Files from a GDUFA II User Fee Perspective

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

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GDUFA II Pre-ANDA Program Meetings: Advice for Success (10of27) Generic Drugs Forum 2018

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GDUFA II User Fees: Update on Year One (21of27) Generic Drugs Forum 2018

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GDUFA

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Completeness Assessments (CAs): Status, KASA for CA, Common Issues \u0026 GDUFA Commitment Letter Stats

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GDUFA II Training - Goals Integration, Ted Sherwood

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

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Introduction: About GDUFA

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GDUFA II Training Review Status Updates, Dawn Kimble-Vance

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GDUFA II Training - Requests for Reconsideration at the Division Level under GDUFA, Priya Shah

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

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GDUFA III MCRM External Training Presentation final

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