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Ann: Immuron Plans IMM-124E Trial to Prevent Travelers Diarrhea, page-3

  1. Dui
    2,081 Posts.
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    A necessary step to take though. Good planning is always better than having to clean up the mess afterwards...in the case of Travellers diarhoea we all know what it means!

    https://www.fda.gov/drugs/cder-smal...ed-questions-pre-investigational-new-drug-ind

    Can pre-IND meetings reduce time to market? Yes, time can be reduced by the following:
    • Identifying and avoiding unnecessary studies
    • Ensuring that necessary studies are designed to provide useful information
    • Gaining FDA support for a proposed strategy
    • Potentially minimizing potential for clinical hold
    • Providing opportunity for creative exchange of ideas
    • Obtaining regulatory insight
    • Minimizing costs
    • Clearly defining endpoints and goals of the development program
    • Allowing early interactions/negotiations with FDA
    Last edited by Dui: 21/11/19
 
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