Quick Overview: Presenters respond to audience questions on CDER's Robert Lionberger, Kris Andre, Dale Conner, Kamal Tiwari, and Katherine Tyner answer audience questions. Presenters respond to audience questions. ----------------------------- FDA CDER's Small Business and Industry Assistance (SBIA) ...
Panel Discussion 31of39 Complex Generics - Detailed Overview & Context
Presenters respond to audience questions on CDER's Robert Lionberger, Kris Andre, Dale Conner, Kamal Tiwari, and Katherine Tyner answer audience questions. Presenters respond to audience questions. ----------------------------- FDA CDER's Small Business and Industry Assistance (SBIA) ... Liang Zhao, Yaning Wang, Robert Lionberger, and Murray Ducharme from Learn and Confirm, Inc., respond to audience ... Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, and Bhagwant Rege respond to audience questions. Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of
Jane Chang from CDER's Office of Pharmaceutical Quality discusses Kelley Burridge, CDER Office of Pharmaceutical Quality (OPQ), discusses OPQ considerations and how to resolve ANDA ... Lisa Bercu, Regulatory Counsel in the Office of Thomas O'Connor, Changning Gou, Patricia Onyimba, Shin (Grace) Chou, Kshitij (Kris) Patkar and Melanie Mueller Caliope Sarago, Fang Yuan, Janice T. Brown and Lei Zhang
