SpeedWeed

AUGUST 16, 2021

During the keynote session titled “Sue’n the DEA: The Story of a Cannabis Research Breakthrough,” Dr. Sisley—a pioneering medical cannabis researcher and volunteer medical director for more than 40 state cannabis licenses—will share her journey on navigating scientific and legal complexities of medical cannabis research. 25 from 11 a.m. –

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Media Clinical Trials DEA Hemp 52

Cannabis Law Report

MARCH 2, 2020

Any approved medicines will have to be rescheduled by the Drug Enforcement Administration (DEA). Back in 2018, the DEA rescheduled GW Pharmaceuticals ‘ (NASDAQ: GWPH) cannabis-based epilepsy medicine, Epidiolex, following its regulatory approval by the FDA. Fortunately, this issue shouldn’t be a show-stopper.

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Medicine Therapy DEA Pharmaceutical 59

The Cannigma

MAY 1, 2023

2 3 As clinical trials around the world proceeded in the late 1960s and 1970s, patients began reporting difficulty tolerating ketamine’s unpleasant hallucinogenic and dissociative properties. Ketamine was approved by the FDA in 1970 and was immediately put to use as an important tool for war medics in the Vietnam War.

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SpeedWeed

MARCH 5, 2021

One, they have been determined by the US Food and Drug Administration to be clinically safe and effective treatments for a specific medical condition. Two, they are federally classified by DEA and HHS as Schedule II, III, IV or V substances. Rescheduling cannabis will not necessarily facilitate clinical research.

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Business Policy Clinical Trials Research and Development 52

Cannabis Law Report

JUNE 4, 2021

In 1996, California legalized medical cannabis yet today, with 37 US States allowing for medical cannabis sales, we still do not have an overall comprehensive cannabis/cannabinoid education program. Consumers, regulators, and legislators remain in the dark on cannabis.

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Canna Law Blog

MAY 7, 2020

Ole Miss got the cannabis study and research cultivation gig from the DEA (via a contract with the National Institute on Drug Abuse (NIDA)) in 1968. This was before implementation of the federal government’s Compassionate Investigational New Drug Program (CINDP), which Ole Miss’s grow now serves in addition to its research.

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DEA Research and Development Cultivation Supply Chain 92

Cannabis Law Report

JULY 9, 2021

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].

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Veriheal

APRIL 11, 2022

He also emphasized the fact that medical cannabis programs are now legal in 37 states, as well as four out of five inhabited U.S. Drug Enforcement Agency (DEA). According to the company’s CEO, George Hodgin, “federally legal FDA- and DEA-approved cannabis-based drugs will absolutely upend the traditional pharmaceutical market.”.

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Pharmaceutical Research and Development DEA Clinical Trials 105

CannaMD

NOVEMBER 15, 2020

As such, universities such as McMaster University and McGill University , among others, have built dedicated and comprehensive research programs. Drug Enforcement Agency (DEA) announced that it will evaluate 37 additional grower applications. The DEA would then be the exclusive distributor. However, things were not all rosy.

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DEA Clinical Trials Cannabinoids Treatment 105

Cannabis Law Report

APRIL 21, 2022

The availability of larger quantities of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use following anticipated regulatory approvals. in each of the four validation trials with an acceptable yield, which is a noteworthy accomplishment.

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Clinical Trials Research and Development Therapy Media 52

Cannabis Law Report

APRIL 8, 2022

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.,

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Clinical Trials Therapy Research and Development DEA 52

MedicalJane

JUNE 29, 2018

Use of CBD in seizure prevention is well-documented with research ; and now, after conducting its own trials, the FDA appears to agree. Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.

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Clinical Trials CBD DEA Research and Development 53

Cannabis Law Report

MAY 29, 2022

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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Research and Development DEA Clinical Trials Therapy 52

Canna Law Blog

JANUARY 3, 2023

Until recently, CBD resided in a legal penumbra where hemp was still scheduled on the federal Controlled Substances Act and could not be cultivated without a permit from the Drug Enforcement Administration (“DEA”). It’s not like the FDA is unaware of the massive unregulated CBD market that already exists in the U.S.

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Cannabis Law Report

APRIL 13, 2022

Complementary businesses combine to create a preeminent North American platform with operations spanning 13 wellness clinics, four research sites and one bioanalytical laboratory. Hosting clinical trials for MDMA ( MAPS Public Benefit Corporation), psilocybin (the Usona Institute), LSD (MindMed) and ketamine (the University of Utah ).

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Clinical Trials Research and Development Therapy Treatment 52

Cannabis Law Report

DECEMBER 21, 2021

It was officially listed on the NYSE in August and granted a DEA schedule I manufacturing license in November. Within a few months, it had completed the first phase of its clinical trial of DMT in combination with supportive psychotherapy and commenced a phase 2a trial. Small Pharma (CVE: DMT ) (OTCMKTS: DMTTF ).

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Clinical Trials Therapy Treatment DEA 52

Canna Law Blog

NOVEMBER 27, 2021

So according to the DEA, its abuse potential is high and it has no medical use. Also, according to the DEA, “the history of human experience probably goes back several hundred years since DMT usage is associated with a number of religious practices and rituals.”

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Therapy Clinical Trials DEA Microdosing 98

NORML

SEPTEMBER 20, 2019

We also spoke with her attorneys, who explained why they believed the DEA broke the law by holding up long-promised medical marijuana research licenses. Essentially, the federal government has monopolized cannabis research, and ElSohly’s product, according to some scientists who’ve seen it, is unsuitable for clinical trials.

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SpeedWeed

DECEMBER 28, 2018

Buzz: Cannabis Equity Programs Expand Opportunities. In late November, Blunt + Moore, the first dispensary to get permitted as part of Oakland, California’s far reaching cannabis equity program, held their grand opening in a small, sleek retail space just across the highway from Oracle Arena, home of the Golden State Warriors.

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Pharmaceutical Research and Development Legalization CBD 40

Cannabis Law Report

JANUARY 14, 2020

Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research. Similar to the MORE Act, this bill from Representative Hakeem Jeffries (D-New York) would also remove marijuana and THC from the list of Schedule I drugs and create a grant program for states and local governments “for marijuana conviction expungement programs.”

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