markbot1999 documents

Vitamin B New Research
Documents Vitamin B New Research
FDA Perspectives - Scientific Considerations of Forced Degradation Studies in ANDA Submissions Ragine Maheswaran MAY 2012
Documents FDA Perspectives - Scientific Considerations of Forced Degradation Studies in ANDA Submissions Ragine Maheswaran MAY 2012
Day1.3 - Lee - A Filing Reviewer's Perspective
Documents Day1.3 - Lee - A Filing Reviewer's Perspective
Day1.5 - Shaw - Drug Master File (DMF) Basics
Documents Day1.5 - Shaw - Drug Master File (DMF) Basics
Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA
Documents Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA
Day2.2 - Lionberger - GDUFA Regulatory Science
Documents Day2.2 - Lionberger - GDUFA Regulatory Science
Day2.3 - Parks - User Fees
Documents Day2.3 - Parks - User Fees
Day2.6 - Park - GDUFA Review Efficiency Enhancements
Documents Day2.6 - Park - GDUFA Review Efficiency Enhancements
Day2.4 - Mozzachio - Post-Approval and Surveillance Inspection
Documents Day2.4 - Mozzachio - Post-Approval and Surveillance Inspection
Day1.2 - Young - An Overview of the Draft Guidance for Industry - ANDA Submissions RTR
Documents Day1.2 - Young - An Overview of the Draft Guidance for Industry - ANDA Submissions RTR
Day1.6 - Zhang - DMFs With a GDUFA Perspective
Documents Day1.6 - Zhang - DMFs With a GDUFA Perspective
Day2.5 - Park - Communication Between FDA and Industry
Documents Day2.5 - Park - Communication Between FDA and Industry
Day1.4 - Lantzy - Optimizing Your eCTD ANDA
Documents Day1.4 - Lantzy - Optimizing Your eCTD ANDA