Topic: FDA Meetings – Getting the Most from the Consult.
TOPIC DESCRIPTION: There are not that many opportunities to consult FDA. FDA meetings (Pre IND, End of Phase 1, End of Phase 2, and other meetings) take an enormous amount of planning and resources. It also takes at least 60 days to receive the FDA responses starting from submitting the meeting request. This presentation will talk about how to plan for a meeting, the timing of the meeting, the data to provide, and, most importantly, how to ask the type of questions to get the information needed to guide your CMC, Nonclinical, and Clinical development programs. After this presentation, the attendee should have an understanding of the types of questions that are appropriate to ask at each stage of development and also when to ask the “forward looking” questions that guide future planning. Getting a “yes” answer from FDA is good, but sometimes getting the “no” is equally important
SPEAKER: Clara Li