The following three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency. Note the fundamental position of the approach in every case:
1) Bring the discussion to the data presented on e.g., the process capability and robustness, acceptance criteria, effectiveness of the analytical capabilities etc.
2) Seek clear understanding of the FDA position
3) Seek agreement that the data package is adequate to support the approach while understanding that the FDA must review the actual NDA submission to come to a final determination
{ 0 comments }
