Ibogaine; authorize SDH to select a consortium to conduct a drug development clinical trial with, to secure FDA's approval of.
An Act To Be Known As The Ibogaine Drug Development Clinical Trial Act; To Authorize The Establishment Of A Consortium To Apply For Selection By The State Department Of Health To Conduct A Drug Development Clinical Trial With Ibogaine And Secure The United States Food And Drug Administration's (fda) Approval Of Ibogaine As A Medication For The Treatment Of Opioid Use Disorder, Co-occurring Substance Use Disorder, And Any Other Neurological Or Mental Health Condition For Which Ibogaine Demonstrates Efficacy; To Require The Consortium To Submit To The Department A Proposal For Purposes Of Conducting An Ibogaine Drug Development Clinical Trial, And Specify What The Proposal Must Include; To Provide That After Selecting A Consortium, The Department Shall Enter Into An Interagency Contract With The Consortium To Provide Funding To Implement The Consortium's Proposed Ibogaine Drug Development Clinical Trial; To Specify What The Interagency Contract Must Include; To Provide That The Department May Not Disburse Funds To Or For A Selected Consortium Under The Interagency Contract Until The Consortium Receives And The Department Verifies The Receipt Of Matching Funds From Sources Other Than The State; To Require The Selected Consortium To Submit An Investigational New Drug (ind) Application With The Fda And Seek A Breakthrough Therapy Designation For Ibogaine From The Fda; To Require The Selected Consortium To Enter Into An Agreement With A Consortium Established By The Government Of Another State That Has Submitted An Investigational New Drug (ind) Application To The Fda And Has Requested A Breakthrough Therapy Designation For Ibogaine From The Fda; To Require The Selected Consortium To Work With The Fda To Coordinate The Drug Development Trial In Mississippi With Ibogaine Drug Development Trials That Are Being Conducted In Other States; To Provide That Only An Institution Of Higher Learning Or A Hospital May Serve As A Trial Site For Conducting An Ibogaine Drug Development
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