Industry and FDA Interactions: What to talk about and when
*Daphne Lin, FDA 


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.