Rob, see exrtact and check out the links below:
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
http://www.fda.gov/cder/Regulatory/applications/ind_page_1.htm
http://www.fda.gov/CDER/HANDBOOK/DEVELOP.HTM
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Rob, see exrtact and check out the links below:Once the IND is...
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