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Presenters Alicia Chen, Susan Levine, Elizabeth Friedman, Beth Goldstein and Orange Book Staff Supervisor Kendra Stewart ... CDER's Office of Pharmaceutical Quality's Hongbio Liao and Office of Utpal Munshi from CDER OGD's Office of Katherine Tyner, Associate Director (acting) Carol Kim and Michael Spagnola, CDER Office of FDA presents on the Current State of Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, and Bhagwant Rege respond to audience questions. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ...
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