Panel Discussion 8 28 Generic Drugs Forum 2017

Summary

Presenters respond to audience questions. FDA CDER's Small Business and Industry Assistance (SBIA) educates and provides ... Presenters Lee, Chandra, Ghodasara, Kimble-Vance, Jiang, Kim, Spagnola, and Golson respond to audience questions. Dawn Kimble-Vance, CDER Office of Michael Kopcha, PhD, RPh, Director, Office of Amy Bertha, CDER Office of Executive Programs, covers Edward “Ted” Sherwood, CDER Office of Kathleen Uhl, MD, Director, Office of Rosanne Chandra and Ankit Ghodasara, CDER Office of Jonathan Resnick, CDER, covers eCTD deadlines, the differences between 1st, 2nd, and 3rd acknowledgement notices, and ... Deputy Director for CDER Clinical and Regulatory Affairs Iilun C. Murphy leads a