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The top documents of markbot1999

Vitamin B New Research
Vitamin B New Research
256 views
Day1.3 - Lee - A Filing Reviewer's Perspective
Day1.3 - Lee - A Filing Reviewer's Perspective
26 views
Day2.6 - Park - GDUFA Review Efficiency Enhancements
Day2.6 - Park - GDUFA Review Efficiency Enhancements
16 views
Day2.4 - Mozzachio - Post-Approval and Surveillance Inspection
Day2.4 - Mozzachio - Post-Approval and Surveillance Inspection
72 views
Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA
Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA
28 views
Day2.2 - Lionberger - GDUFA Regulatory Science
Day2.2 - Lionberger - GDUFA Regulatory Science
34 views
Day1.5 - Shaw - Drug Master File (DMF) Basics
Day1.5 - Shaw - Drug Master File (DMF) Basics
42 views
Day1.2 - Young - An Overview of the Draft Guidance for Industry - ANDA Submissions RTR
Day1.2 - Young - An Overview of the Draft Guidance for Industry - ANDA Submissions RTR
226 views
Day1.4 - Lantzy - Optimizing Your eCTD ANDA
Day1.4 - Lantzy - Optimizing Your eCTD ANDA
216 views
Day1.6 - Zhang - DMFs With a GDUFA Perspective
Day1.6 - Zhang - DMFs With a GDUFA Perspective
221 views
Day2.5 - Park - Communication Between FDA and Industry
Day2.5 - Park - Communication Between FDA and Industry
218 views