Thanks WL
Investigational New Drug (IND) Application
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/HowDru
sareDevelopedandApproved/ApprovalApplications/Investigatio
alNewDrugINDApplication/default.htm
Would that apply to OXY trials?
Thanks WLInvestigational New Drug (IND) ApplicationOnce the IND...
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