Cannabis Law Report

JUNE 3, 2021

A Seattle palliative care physician has filed a lawsuit against the DEA, contesting its decision to ban psilocybin for use by terminally ill patients.

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DEA Access Clinical Trials Patients 98

NORML

JANUARY 17, 2019

A bipartisan coalition of House lawmakers has introduced The Medical Cannabis Research Act of 2019 ( HR 601 ), to facilitate federally-approved clinical trials involving cannabis. Click here to send a message to your Representative and urge them to support the measure. . The agency ultimately rejected her decision.

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Clinical Trials Legislation DEA Strains 234

Cannabis Law Report

NOVEMBER 4, 2021

Drug Enforcement Agency (DEA) to cultivate marijuana for research purposes. The DEA dragged their feet on this plan for years, so lawsuits were filed. Litigation against the DEA and Department of Justice that Matthew Zorn and I brought on behalf of Dr. Since then, the DEA has licensed four additional bulk manufacturers of marijuana.

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DEA Clinical Trials Advocacy Legislation 52

Cannabis Law Report

APRIL 12, 2022

Attorneys representing a cannabis biopharma conglomerate and federal cannabis cultivation license applicant filed a petition in court today, citing that the Drug Enforcement Agency (DEA) is taking too long to issue a determination for its application. . Breaking Exclusive: Another Cannabis Company Sues the DEA. Read more at.

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DEA Cultivation Clinical Trials Cannabis 52

SpeedWeed

SEPTEMBER 4, 2021

The DEA published a new document in the Federal Register on September 2 requesting an increase in production for certain Schedule I and Schedule II substances so that it can initiate more research studies. . DEA firmly believes in supporting regulated research of schedule I controlled substances. View original article.

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DEA Research and Development Clinical Trials Extraction 52

Cannabis Law Report

NOVEMBER 22, 2019

MMJ International Holdings, the premier medical cannabis research company, announced that it has received DEA approval to ship THC and CBD from Canada. ”We are pleased with the DEA ‘s cooperation and support to facilitate our company mission to service the unmet needs of patients suffering from these chronic diseases.”

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DEA Clinical Trials THC Research and Development 66

NORML

MARCH 1, 2019

” 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. Patterson said that DEA could not move forward granting any new applications until the Justice Department clarified the issue. .”

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DEA Research and Development Clinical Trials Marijuana 172

Cannabis Law Report

SEPTEMBER 4, 2021

Much of the argument, before Circuit Judges Mark Bennett, Sandra Ikuta and Ryan Nelson, focused on whether the DEA’s conclusion that it could not waive any part of the federal Controlled Substances Act (CSA), which bans psilocybin except for limited research purposes, could even be appealed. Forty-one states have passed such laws.

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Clinical Trials Law DEA Patients 109

Cannabis Law Report

MARCH 30, 2022

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. The full text of S. 253 is online here.

Legislation 95

Legislation Clinical Trials DEA Access 95

Veriheal

JUNE 30, 2023

For their analysis, researchers conducted qualitative interviews with 13 individuals who had participated in a psilocybin clinical trial. The 13 individuals were chosen because of their reported improvements in negative drinking behavior following the clinical trial.

Clinical Trials 92

Clinical Trials Research and Development Therapy Policy 92

Cannabis Law Report

FEBRUARY 10, 2022

Court of Appeals for the Ninth Circuit dismissed a petition for review of a Drug Enforcement Administration (DEA) response to an attorney’s letter seeking advice and guidance on how a physician could administer psilocybin to a terminally ill patient without incurring liability under the Controlled Substances Act (CSA). By Allison Campbell.

DEA 52

DEA Clinical Trials Policy Research and Development 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 87

Cannabis Law Report

MAY 31, 2022

The only psychedelic drug that is approved (outside of clinical trials) for psychiatric use—as opposed to anesthesia—through the traditional medical system is Ketamine. The Drug Enforcement Agency (DEA) currently has guidance published for those interested in petitioning for a religious exemption to the CSA. Schedule I.

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Clinical Trials Legalization Therapy Decriminalization 52

NewsMunchies

NOVEMBER 12, 2021

In clinical trials, psilocybin (the psychoactive substance in mushrooms) has shown tremendous promise in treating severe depression, post-traumatic stress disorder, and other mental illnesses. Additional clinical trials underway in the U.S. We know such categorization is baseless and false.

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Clinical Trials Therapy Decriminalization DEA 90

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

Cannabis Law Report

OCTOBER 4, 2021

A multitude of recent clinical trials shows the clear promise of psilocybin for this population suffering from these debilitating conditions. This is a policy where the federal government, the DEA, will refrain from taking prosecutorial action if state law permits, regulates, and carefully controls the use of a drug.

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Therapy Patients Law Clinical Trials 52

SpeedWeed

JULY 23, 2021

When you’re talking about wanting to do an actual clinical trial, you need a diversity of people that participate and one state just does not have the diversity of people that are required,” Towle said. Denver Company Moves Forward with Research License . Denver’s MedPharm Drives Research Further.

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Clinical Trials Research and Development DEA Cannabinoids 52

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

SpeedWeed

AUGUST 11, 2021

This will be the second clinical trial to give cannabis medicine or placebos to participating military veterans, and according to the Chief Science Officer of the MAPS Public Benefit Corporation, Berra Yazar-Klosinki, PhD, the first trial was a great success. “We MAPS Makes History.

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Clinical Trials Research and Development Pharmaceutical DEA 52

Cannabis Law Report

MARCH 18, 2022

Food and Drug Administration (FDA) guidance on clinical trials, Drug Enforcement Agency (DEA) licensing, material transfer agreements and cooperative research and development agreements (CRDA). The firm’s multidisciplinary team covers commercial, regulatory and legal requirements spanning U.S.

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Therapy Research and Development Clinical Trials Environment 52

Cannabis Law Report

SEPTEMBER 20, 2019

The sale will greatly reduce the current and future burn rate of the company and allow it to focus on achieving profitability, seeking a DEA license, and implementing GMP, a set of regulations promulgated by the U.S. location.

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Clinical Trials Research and Development DEA Business 40

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

Veriheal

APRIL 11, 2022

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.”. Groff confirmed that it had completed its first batch of medicinal-grade cannabis for research purposes on Feb.

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Pharmaceutical Research and Development DEA Clinical Trials 104

Cannabis Law Report

OCTOBER 5, 2021

The drug has previously been used with some success in clinical trials designed to treat depression. These trials typically involve the use of music playlists to support the psychedelic experience.

Clinical Trials 52

Clinical Trials Research and Development DEA Therapy 52

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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Law Therapy Clinical Trials Research and Development 105

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. –

Media 52

Media Clinical Trials DEA Hemp 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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CBD Food Clinical Trials Pets 75

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

Cannabis Law Report

FEBRUARY 28, 2022

Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. 1025, 1026 (2021) (reporting significant improvement of PTSD symptoms following treatment with MDMA in clinical trial); see also Alec J. Mitchell et al., Divito & Robert F. 15 × 15. 16 × 16.

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Research and Development Therapy Law Clinical Trials 52

SpeedWeed

MARCH 25, 2021

A long-awaited clinical trial on using cannabis as a treatment for veterans with PTSD has finally been published in the PLOS One journal , but the results are far less promising than researchers and veterans had hoped. million grant from the Multidisciplinary Association of Psychedelic Studies (MAPS).

DEA 52

DEA Clinical Trials THC Pharmaceutical 52

CannaMD

AUGUST 8, 2020

Drugs, substances, and certain chemicals used to make drugs are classified into five categories (known as schedules ) depending on the Department of Drug Enforcement Agency (DEA)’s definition of the drug’s acceptable medical use and abuse/dependency potential. CBD Scheduling Rule Change. But the government is clear.

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CBD DEA Research and Development Hemp 99

SpeedWeed

MARCH 18, 2021

for the production of cannabis used in federally-regulated clinical trials. Wasn’t the DEA going to let others grow research-grade cannabis? Early on in the study, criticism over the poor quality and low potency of the NIDA-supplied cannabis prompted Johns Hopkins University to withdraw from the multi-year clinical trials.

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Clinical Trials THC Strains Cannabis 40

Cannabis Law Report

AUGUST 18, 2022

Study and development of these treatments remain challenging as psilocybin, MDMA, DMT and LSD are all listed as DEA Schedule I drugs. However, change appears imminent.

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Therapy Research and Development Pharmaceutical Treatment 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.

Medicine 59

Medicine Therapy DEA Pharmaceutical 59

NORML

APRIL 8, 2020

Under existing regulations, the agency only licenses one facility — the University of Mississippi — to cultivate cannabis for use in FDA-approved clinical trials. To date, however, the DEA has failed to either affirm or reject any of the more than 30 applications it has received.

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Cultivation DEA Clinical Trials Marijuana 354

Weedistry

MARCH 7, 2019

A team of Spanish scientists led by Manuel Guzman conducted the first clinical trial assessing the antitumoral action of THC on human beings. Guzman administered pure THC via a catheter into the tumors of nine hospitalized patients with glioblastoma, who had failed to respond to standard brain-cancer therapies.

THC 40

THC CBD Clinical Trials Research and Development 40

Veriheal

JUNE 24, 2021

Collins has said that the DEA recently “granted permission to expand the number of research marijuana providers” but that the best solution would still be to remove cannabis from its scheduling and to alter the scheduling of other psychedelics to make the much-needed researcher easier. .

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Research and Development Clinical Trials Treatment Access 52