Industry and FDA Interactions: What to talk about and when
*Daphne Lin, FDA Keywords: To discuss how and when the FDA and industry interact through different stages of drug development, that is from pre-IND, to IND, to NDA, and to post approval stages. FDA’s internal timeline for review processes and how FDA coordinates review team activities will be covered. The purposes of several important meetings, such as, pre-IND meeting, end of Phase II meeting, pre-NDA meeting, advisory committee meeting, .. etc. will be discussed from statistical perspectives. Finally, selected statistical issues at different stages of drug development that are frequently encountered will be discussed.
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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