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Court Dismisses Case Demanding DEA to Move Expeditiously to License Cannabis Cultivators

NORML

Justices for the US Court of Appeals for the District of Columbia denied the petition following a filing by DEA in the Federal Register stating that the agency “intends to promulgate regulations” to review several dozen federal cultivation applications.

DEA 103
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NORML “Senate Unanimously Approves Legislation Providing US Attorney General with Greater Say in Cannabis Research Decisions”

Cannabis Law Report

Senate Bill 253: The Cannabidiol and Marihuana Research Expansion Act provides the office of US Attorney General, rather than the US Drug Enforcement Administration, the discretion to license scientists to engage in clinical trials involving the use of cannabis by human subjects.

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Justice Department Urged To Take “Immediate Action” On Marijuana Grow Applications

NORML

Currently, the sole federally licensed producer of cannabis for clinical research is the University of Mississippi. ” Last year, however, former DEA director Robert Patterson testified to Congress that the agency believed that approving additional applicants would likely violate international anti-drug treaties. .”

DEA 161
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Senators Call For Report On State Of Psychedelic Research

Cannabis Law Report

8] Spravato is derived from ketamine and categorized by DEA as a Schedule III controlled substance. Clinical Trials and Human Subject Protections. Before the drug approval process even begins, sponsors must initiate clinical investigations by first filing an Investigational New Drug Application (IND) with FDA.

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New Frontiers in the Law of Psychedelics

Cannabis Law Report

Then, in November 2019, the FDA granted the designation to the nonprofit Usona Institute to study psilocybin’s effect on major depressive order, for which clinical trials are currently under way. See Usona Institute, A Study of Psilocybin for Major Depressive Disorder (MDD) , Clinical Trial ID NCT03866174, available at [link].

Law 105
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NORML Formally Responds to DEA’s Proposed Changes to Marijuana Cultivation Rules

NORML

Under existing regulations, the agency only licenses one facility — the University of Mississippi — to cultivate cannabis for use in FDA-approved clinical trials. In 2016, the agency appeared to reconsider its longstanding policy, and publicly stated for the first time that it would consider additional applicants.

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MAPS Is 36 Years Old – Doblin Provides Precis Timeline of the Organization

Cannabis Law Report

This year, we are completing the second Phase 3 clinical trial of MDMA-assisted therapy for PTSD , the final stage prior to requesting FDA approval for a new prescription treatment to help heal trauma. Later that year, Doblin sued the DEA for the first time. Rick Doblin, Ph.D., and Michael Mithoefer, M.D., Lyle Craker, Ph.D.,