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End-of- Phase 2 (EOP-2)
End-of-Phase 2 (EOP-2)
End-of-phase 2 (EOP2) or Pre-phase 3 meetings are formal PDUFA Type B meetings held between IND sponsors and CDER or CBER to determine the safety of proceeding to Phase 3, and to evaluate: the Phase 3 plan and protocols, the adequacy of current studies and plans to assess pediatric safety and effectiveness. This type of meeting can be very useful in minimizing wasteful expenditures of time and money, speeding up the drug development and evaluation process.