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 236

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

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

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 170

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

Cannabis Law Report

OCTOBER 4, 2021

In Attorney , Federal Law , Kathryn Tucker , Oregon , Psychedelics. A multitude of recent clinical trials shows the clear promise of psilocybin for this population suffering from these debilitating conditions. Access to Psilocybin Therapy Pursuant to Right to Try Laws. September 30, 2021. Kathryn Tucker.

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Therapy Patients Law Clinical Trials 52

Cannabis Law Report

JULY 9, 2021

The state of the law on psychedelic substances is in flux. Some of the most promising substances, and the law applicable to each, are outlined below: Psilocybin. As such, the use, sale, and possession of psilocybin in the United States is illegal under federal law. have also passed “Right to Try” laws.

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Law Therapy Clinical Trials Research and Development 105

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.

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Legislation Clinical Trials DEA Access 95

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.

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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.” Compass Pathways Releases Phase 2B Trial Results.

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Therapy Clinical Trials DEA Microdosing 87

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. The War on Drugs is a failure and continuing to focus law enforcement resources on people using cannabis and psilocybin doesn’t make sense.

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Clinical Trials Therapy Decriminalization DEA 90

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. How will the federal government react to another new industry that operates in clear violation of the federal black letter law? On March 5, 2019, the U.S.

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Clinical Trials Legalization Therapy Decriminalization 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

Cannabis Law Report

MARCH 18, 2022

Many of these drugs are regulated by a patchwork of state and federal laws regulating Schedule I controlled substances. The establishment of the firm’s Psychedelics and Emerging Therapies team makes Husch Blackwell the first Am Law 100 firm to create a practice devoted to serving the psychedelics industry.

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Therapy Research and Development Clinical Trials Environment 52

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

Veriheal

APRIL 11, 2022

federal law , it has not yet been used in any commonly prescribed medicines. The company initiated the first legal transfer (as deemed by federal law) to the U.S. Drug Enforcement Agency (DEA). federal law. federal law, from which point, informed choices can be made about the use of cannabis and cannabinoids.

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Pharmaceutical Research and Development DEA Clinical Trials 104

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

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

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

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.

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Clinical Trials Research and Development DEA Therapy 52

Cannabis Law Report

JANUARY 11, 2019

federal law protects the retail sale of hemp-derived CBD. . Our analysis follows: Hemp-derived CBD is no longer a controlled substance under federal law. The FDA’s position on CBD is unsettled and unsupported by law. While the DEA is now officially out of the hemp regulation business, the U.S.

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Hemp CBD Law Seed-To-Sale 49

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. 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

With rapid change expected in state and federal laws and regulations governing the industry, we understood the urgency of launching a practice team that provides sophisticated legal counsel bolstered by deep knowledge of science and the pace of innovation.” However, change appears imminent.

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Therapy Research and Development Pharmaceutical 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

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

APRIL 1, 2019

It aims to turn the plants’ chemical compounds into 2,500 5-milliliter bottles – the size of a teaspoon – of cannabis oil and sublingual drops for clinical trials among volunteer patients as early as July. 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

NORML

APRIL 8, 2020

The National Organization for the Reform of Marijuana Laws (NORML) has formally submitted comments to the US Federal Register opposing the Drug Enforcement Administration’s proposed rule changes governing the federal production and distribution of cannabis for clinical research purposes.

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Cultivation DEA Clinical Trials Marijuana 355

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

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

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. Essay: “The Nature of Hemp and Law: Hazy Regulation”. Jack Devanna . School: The University of Rhode Island.

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Research and Development Education Agriculture Patients 117

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. Today there are 41 states that have enacted some form of a Right to Try or RTT laws. Patients Are Not In This Alone.

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Therapy DEA Patients Clinical Trials 53

Canna Law Blog

NOVEMBER 6, 2021

But despite increasing acceptance by the public, and commercial investment in psychedelic therapies, aging federal laws stem the flow of vital research. Research was permitted in the mid-20th century, until the law stepped in. Instead, qualifying evidence may come from adequate and well-controlled clinical trials.

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Clinical Trials DEA Research and Development Therapy 98

Cannabis Law Report

JUNE 4, 2021

This has not yet been enforced or brought to a court of law and again I will make the analogy to beer and wine in the alcohol industry (equivalent to Delta-8) vs hard liquor (more equivalent to Delta-9). Delta-8 appears to us at Cannabis Law Report, the canary in the coal mine for new cannabis compounds.

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Research and Development Seed-To-Sale Cannabinoids THC 105

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.

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Therapy Legalization Chronic Pain DEA 89

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

Veriheal

DECEMBER 21, 2022

President Joe Biden has officially signed a marijuana research bill into law. The law gives the U.S. The law gives the U.S. The Drug Enforcement Administration (DEA) is now mandated to approve applications to be manufacturers of marijuana-derived, FDA-approved drugs under the bill.

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Clinical Trials Marijuana Decriminalization History 98