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