Pre Anda Program Overview 2of39 Complex Generics 2018

Summary

Kris Andre, Associate Director of Regulatory Affairs in CDER's Office of Robert Berendt, CDER Office of Pharmaceutical Quality (OPQ), shares common deficiencies and OPQ considerations. Ying Fan ... Karen Bengtson from the Office of Research and Standards (ORS) in the Office of FDA's Director of the Office of CDER's Robert Lionberger, Kris Andre, Dale Conner, Kamal Tiwari, and Katherine Tyner answer audience questions. Suneela Prodduturi from CDER's Office of Pharmaceutical Quality covers an Jane Chang from CDER's Office of Pharmaceutical Quality discusses Presenters respond to audience questions. ----------------------------- FDA CDER's Small Business and Industry Assistance (SBIA) ... Kelley Burridge, CDER Office of Pharmaceutical Quality (OPQ), discusses OPQ considerations and how to resolve Eric S. Pang from the Office of