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Presenters Katherine Tyner, Christine Le, Bhagwant Rege, Kris Andre Presenters Larry Lee, Tony Huang, Vidya Pai Kris Andre, Jonathan Resnick, and Ethan Chen Presenters Aiden Nguyen, Varun Vasudeva, Dat Doan, Ke Ren and Julia Lee Presenters Nusie Motlekar, Frank Holcombe, Om Anand, Hongbio Liao, and Victoria Keck Presenters Alicia Chen, Susan Levine, Elizabeth Friedman, Beth Goldstein and Orange Book Staff Supervisor Kendra Stewart ... This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ... Katherine Tyner, Associate Director (acting) Edward “Ted” Sherwood, CDER Office of CDER Office of Business Informatics' Chao (Ethan) Chen presents recent updates of the FDA Study Data Technical Rejection ...
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