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Day2.5 - Park - Communication Between FDA and Industry

Day2.5 - Park - Communication Between FDA and Industry

Category: Documents
Released: May 18, 2017
Day1.6 - Zhang - DMFs With a GDUFA Perspective

Day1.6 - Zhang - DMFs With a GDUFA Perspective

Category: Documents
Released: May 18, 2017
Day1.4 - Lantzy - Optimizing Your eCTD ANDA

Day1.4 - Lantzy - Optimizing Your eCTD ANDA

Category: Documents
Released: May 18, 2017
Day1.2 - Young - An Overview of the Draft Guidance for Industry - ANDA Submissions RTR

Day1.2 - Young - An Overview of the Draft Guidance for Industry - ANDA Submissions RTR

Category: Documents
Released: May 18, 2017
Day2.4 - Mozzachio - Post-Approval and Surveillance Inspection

Day2.4 - Mozzachio - Post-Approval and Surveillance Inspection

Category: Documents
Released: January 20, 2016
Day2.2 - Lionberger - GDUFA Regulatory Science

Day2.2 - Lionberger - GDUFA Regulatory Science

Category: Documents
Released: October 17, 2015
Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA

Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA

Category: Documents
Released: October 17, 2015
Day1.5 - Shaw - Drug Master File (DMF) Basics

Day1.5 - Shaw - Drug Master File (DMF) Basics

Category: Documents
Released: October 17, 2015
Day1.3 - Lee - A Filing Reviewer's Perspective

Day1.3 - Lee - A Filing Reviewer's Perspective

Category: Documents
Released: November 25, 2015
Day2.6 - Park - GDUFA Review Efficiency Enhancements

Day2.6 - Park - GDUFA Review Efficiency Enhancements

Category: Documents
Released: December 29, 2015
Vitamin B New Research

Vitamin B New Research

Category: Documents
Released: February 20, 2015