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Innovation Pharmaceuticals IPIX
Posted On: 05/27/2016 12:22:27 PM
Post# of 72447
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Posted By: sox0407
Re: scottsmith #23099
"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













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