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. Senate members in 2020 passed a similar version of S.

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Legislation Clinical Trials DEA Access 95

Cannabis Law Report

MAY 31, 2022

The short answer is: that current legal options (i.e. legal at the state level or the state and federal level) are limited. 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. Federal Legal Status.

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Clinical Trials Legalization Therapy Decriminalization 52

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

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.

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Clinical Trials Research and Development Therapy Policy 92

NewsMunchies

NOVEMBER 12, 2021

As the cannabis industry continues to grow and evolve with legalization achieved in many parts of the world, we’re seeing an increase in activity related to another substance that will hopefully be removed from the list of controlled substances – psilocybin. Additional clinical trials underway in the U.S.

Clinical Trials 90

Clinical Trials Therapy Decriminalization DEA 90

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.” Psychedelic Decriminalization and Legalization Roundup.

Therapy 87

Therapy Clinical Trials DEA Microdosing 87

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. However, this drug is not presently legally available, as it is classified as a Schedule I drug, severely restricted and regulated by the federal Controlled Substances Act.

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Therapy Patients Law Clinical Trials 52

Cannabis Law Report

MAY 29, 2022

In 2020, Oregon became the first locale to decriminalize psilocybin and legalize it for therapeutic use on a statewide basis. 8] Spravato is derived from ketamine and categorized by DEA as a Schedule III controlled substance. Clinical Trials and Human Subject Protections. DEA and the Controlled Substances Act.

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Research and Development DEA Clinical Trials Therapy 52

Cannabis Law Report

MARCH 18, 2022

Similar to the early days of the medical cannabis movement, psychedelic drugs such as MDMA, psilocybin, LSD, ketamine and DMT are being developed for therapeutic use in a complex and difficult legal and regulatory environment. The firm’s multidisciplinary team covers commercial, regulatory and legal requirements spanning U.S.

Therapy 52

Therapy Research and Development Clinical Trials Environment 52

Cannabis Law Report

FEBRUARY 28, 2022

Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. This Essay analyzes the ethical, legal, and social implications of patenting these controversial substances. Trial of Psilocybin Versus Escitalopram for Depression , 384 NEW ENG. Mitchell et al.,

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Research and Development Therapy Law Clinical Trials 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.

Clinical Trials 52

Clinical Trials Research and Development Therapy Media 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. “The

Clinical Trials 52

Clinical Trials Research and Development DEA Cannabinoids 52

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. The company initiated the first legal transfer (as deemed by federal law) to the U.S. Drug Enforcement Agency (DEA). territories. What Cannabis-Based Medicines Have Been Approved So Far?

Pharmaceutical 104

Pharmaceutical Research and Development DEA Clinical Trials 104

Cannabis Law Report

JULY 9, 2021

This article provides an overview of the current state of legality of common psychedelic substances, and some of the potential therapeutic uses to which psychedelics may be applied. As part of the same state-wide initiative, Oregon legalized the use of psilocybin for medical purposes. Drug Enforcement Agency (“DEA”).

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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. 24-26, 2021.

Media 52

Media Clinical Trials DEA Hemp 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.

Clinical Trials 53

Clinical Trials CBD DEA Research and Development 53

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”). Now though, it sounds like FDA is serious about CBD regulations in the context of both food and supplements.

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CBD Food Clinical Trials Pets 75

CannaMD

AUGUST 8, 2020

But CBD’s real calling card is that it’s popularly isolated from marijuana’s sibling plant, hemp , and can be legally sold (in most states) under much more relaxed regulations. One big myth is that the Farm Bill makes hemp-derived CBD legal. However, there are a number of restrictions. CBD Scheduling Rule Change.

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CBD DEA Research and Development Hemp 99

Cannabis Law Report

AUGUST 18, 2022

Among the first in the nation, Phillips Lytle’s Psychedelics Practice Team combines expertise in pharmaceutical science, FDA regulations and risk management to serve the legal needs of emerging bio-tech sectors. Promising research in psychedelics as a mental health treatment accelerates growth of industry in need of legal counsel.

Therapy 52

Therapy Research and Development Pharmaceutical Treatment 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

Cannabis Law Report

MARCH 2, 2020

The global march toward cannabis legalization has seemingly awoken another long dormant area of scientific interest: psychedelics as medicine. Psychedelic medicine offers investors several key advantages over legal cannabis. Any approved medicines will have to be rescheduled by the Drug Enforcement Administration (DEA).

Medicine 59

Medicine Therapy DEA Pharmaceutical 59

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

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 349

Veriheal

AUGUST 31, 2020

However, social and economic barriers like racial stereotypes and lack of access to care centers have historically barred Hispanic community members from seeking medical cannabis and participating in clinical trials. About Clinton: Clinton is an undergraduate student studying business.

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Research and Development Education Agriculture Patients 117

Cannabis Law Report

APRIL 1, 2019

The other, the Government Pharmaceutical Organization, or GPO, broke ground in February to grow Thailand’s first legal cannabis plants indoors at its ultra-modern pharmaceutical factory in Bangkok’s northern suburbs. It remains to be seen whether the Drug Enforcement Authority, or DEA, will designate cannabis zones for these farmers.

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Research and Development Pharmaceutical Clinical Trials DEA 40

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.

Business 52

Business Policy Clinical Trials Research and Development 52

Cannabis Law Report

JANUARY 11, 2019

Questions continue to be raised, however, about the legality of one of the country’s most popular hemp products, hemp-derived cannabidiol (CBD). Hemp Roundtable, the industry’s leading business advocate for the full and permanent legalization of hemp and hemp products, strongly believes that U.S.

Hemp 49

Hemp CBD Law Seed-To-Sale 49

Veriheal

JUNE 29, 2021

In order to legally access other therapies including nature-based options such as psilocybin , you must gain access under a Right to Try law which requires you to have a terminal condition. The lawsuit came after the DEA denied their application to utilize a synthetic form of psilocybin under the RTT laws.

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Therapy DEA Patients Clinical Trials 53

Canna Law Blog

NOVEMBER 6, 2021

The following year, President Richard Nixon declared drug abuse public enemy number one, and in 1973, he formed the Drug Enforcement Administration (DEA). Instead, qualifying evidence may come from adequate and well-controlled clinical trials. Phase I trials should be sufficient, and many have been completed using psilocybin.

Clinical Trials 98

Clinical Trials DEA Research and Development Therapy 98

Cannabis Law Report

JUNE 4, 2021

If the Federal Analogue Rule were to be more strictly enforced, then this may be the only pathway to legally sell Delta-8. 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.

Research and Development 105

Research and Development Seed-To-Sale Cannabinoids THC 105

Canna Law Blog

MARCH 4, 2020

Similar to ketamine, psilocybin has shown great promise in clinical trials for helping to effectively treat depression and PTSD (and we’ve written about psilocybin several times on this blog, including here and here ). This post is dedicated to clearing up some of the confusion behind ketamine clinic set-up and operation.

Therapy 89

Therapy Legalization Chronic Pain DEA 89

SpeedWeed

MARCH 28, 2021

CANNABIS CULTURE – The results are now in after the first-ever legal clinical trial into the use of cannabis to treat PTSD, but did the DEA’s rules taint the outcome? Seventy-six mostly male veterans between the ages of 24 and 77 completed the Phase 1 trial.

Clinical Trials 52

Clinical Trials DEA Treatment THC 52

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. for various studies, including FDA-approved clinical trials. In 2016, the DEA finally shifted to different treatment around expanded research efforts into cannabis beyond Ole Miss.

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DEA Research and Development Cultivation Supply Chain 70

Canna Law Blog

MARCH 4, 2020

Similar to ketamine, psilocybin has shown great promise in clinical trials for helping to effectively treat depression and PTSD (and we’ve written about psilocybin several times on this blog, including here and here ). This post is dedicated to clearing up some of the confusion behind ketamine clinic set-up and operation.

Legalization 52

Legalization Therapy Chronic Pain DEA 52

Veriheal

DECEMBER 21, 2022

The Drug Enforcement Administration (DEA) is now mandated to approve applications to be manufacturers of marijuana-derived, FDA-approved drugs under the bill. Rescheduling cannabis and decriminalizing cannabis do not mean the same thing for federal legalization. The law gives the U.S.

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Clinical Trials Marijuana Decriminalization History 98

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

APRIL 8, 2022

as a non-profit organization to fulfill the need to broaden psychedelic research, therapy, and develop legal options for psychedelic medicine. Now, we are closer than ever to legalizing MDMA-assisted therapy for posttraumatic stress disorder (PTSD), though there is still a long road ahead. Rick Doblin, Ph.D., Rick Doblin, Ph.D.,

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Clinical Trials Therapy Research and Development DEA 52