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ed8

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ed8

Re: None

Tuesday, 03/05/2013 2:54:58 PM

Tuesday, March 05, 2013 2:54:58 PM

Post# of 158400
FDA has 30 Calendar days
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/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
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