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Last Updated: September 26, 2026
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A presentation and panel discuss potential gaps in Yiwei Li from CDER's Office of Pharmaceutical Quality shares a case study, an introduction to Iron Colloid Drug Asif Rasheed from the Office of Pharmaceutical Quality discusses common issues and challenges for Rachel Dunn, PhD, Director of the Division of Pharmaceutical FDA discusses additional topics in Deyi Zhang from the Office of Research and Standards in the Office of Generic Drugs covers Active Pharmaceutical Ingredient ... Satish Sharan from CDER's Office of Generic Drugs discusses application of modeling and simulation in establishing appropriate ... Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ... Xiaoming Xu from the CDER Office of Pharmaceutical Division of Xiajing (Jean) Gong from CDER Office Generic Drugs' Division of Quantitative Methods and Modeling discusses ... Presentations discuss perspectives on generic industry challenges. Topics and titles as follows: Model-Integrated Evidence for ...
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