RL01 Effective Communication with an FDA Statistician
*Aloka Chakravarty, U.S Food and Drug Administration Keywords: 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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC