Strategies To Demonstrate Complex Api Sameness 10of35 Complex Generics %e2%80%93 Sep 25 26 2019

Summary

Deyi Zhang from the Office of Research and Standards in the Office of Cameron Smith from the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality covers the regulatory pathway for ... Liang Zhao, Yaning Wang, Robert Lionberger, and Murray Ducharme from Learn and Confirm, Inc., respond to audience ... Lisa Bercu, Bing Cai, Kimberly Witzmann, Office of Xiaoming Xu from the CDER Office of Pharmaceutical Division of Product Quality provides an overview of research, development, ... Karen Bengtson from the Office of Research and Standards (ORS) in the Office of Bin Qin from the Division of Therapeutic Performance in the Office of Presenters Karen Bengtson, Suneela Prodduturi and Susan Zuk answer audience questions. Learn more at ... Deyi Zhang from CDER's Office of Andrew J. Fine from the Division of Clinical Review in the Office of Liang Zhao from the Division of Quantitative Methods and Modeling in the Office of Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ... Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, and Bhagwant Rege respond to audience questions.