RL01 Effective Communication with an FDA Statistician
*Aloka Chakravarty, U.S Food and Drug Administration 


Effective communication with the FDA is an essential part of the drug development and approval process. This discussion will focus on suggestions, feedback and examples of how to improve communication through the use of standards. Improving communication with the FDA during drug development and on streamlining the processes involved in submission and review through the use of standards like pre-NDA meetings, CDISC and controlled computing environments will be shared. This is a follow-up discussion on a session on this topic at a previous FDA-Industry Workshop.