Panel Discussion 20of27 Generic Drugs Forum 2018

Summary

Presenters Khanna, Bearr, Shen, Smith, Munshi, Patel, Mbi, Sansone, Julia Lee, and Andrea Bautista answer audience questions. Presenters Sherwood, Chazin, Hasselbalch, Bercu, Andre, Resnick and Kurtz respond to audience questions. Learn more at ... Presenters Friedman, Shen, Tyner, Andre, and Kendra Stewart respond to audience questions. Learn more at ... Presenters Ryan, Jao, Rodriguez, Anh Bui, Nguyen, Randad, Berendt, and Parks respond to audience questions. Learn more at ... CDER's Jonathan Resnick covers points to consider when preparing an eCTD submission and sending to FDA. Learn more at ... Presenters respond to audience questions. ----------------------------- FDA CDER's Small Business and Industry Assistance (SBIA) ... Presenters Lee, Chandra, Ghodasara, Kimble-Vance, Jiang, Kim, Spagnola, and Golson respond to audience questions. CDER's Vincent Sansone provides an overview of GDUFA II goal dates and how they are applied to original applications, ... Elizabeth Bearr from CDER's Office of Office of Howard Chazin, Linda Forsyth, Lauren Gilles, Niles Ron, and Debra Catterson Thomas O'Connor, Changning Gou, Patricia Onyimba, Shin (Grace) Chou, Kshitij (Kris) Patkar and Melanie Mueller