"1) End-of-Phase 2 meetings --(i) Purpose. The pur

"1) End-of-Phase 2 meetings --(i) Purpose. The purpose of an end-of-phase 2 meeting is to determine the safety of proceeding to Phase 3 , to evaluate the Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a marketing application for the uses under investigation."

https://www.accessdata.fda.gov/scripts/cdrh/c...?fr=312.47