The Blunt Truth

DECEMBER 23, 2020

In quick succession, the Food & Drug Administration (FDA) announced yesterday, December 22 nd , that it issued five warning letters to companies for selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Canna Care Docs

OCTOBER 3, 2023

Conventional medication methods such as opiates may help terminal patients focus on more palliative treatment options and goals in order to better one’s comfort and overall quality of life during this time. One study from the Journal of Clinical Oncology examined the efficacy of cannabinoids in appetite stimulation.

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Chronic Pain Clinical Trials Patients Cannabinoids 105

The Cannigma

MARCH 7, 2022

A 2012 study in rats compared the effects of CBD, CBG, and CBN on food consumption and showed that unlike the others, CBN increased feeding. What can the current clinical trials tell us? It is exploring the treatment of pain from osteoarthritis with cannabinoid ratios – specifically, CBD + CBN and CBD + THC versus placebo.

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THC Sleep Clinical Trials Cannabinoids 140

Cannabis Law Report

AUGUST 3, 2021

Cybin is a leading biotechnology company focused on progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric disorders. Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products.

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Clinical Trials Events Treatment Banking 105

Cannabis Law Report

NOVEMBER 19, 2021

“These additional patent filings are key as PsyBio moves towards the initiation of appropriately approved safety and efficacy clinical trials for our selected compounds within the production and manufacturing arena, for the Company as well as for our investors.”

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Clinical Trials Research and Development Events Safety 52

Cannabis Law Report

OCTOBER 13, 2021

The PCT filing also includes support for future research programs respecting various systems which seek to minimize negative side effects in psychedelic psychotherapy patients, methods that enable lower and sub-psychedelic doses without impacting treatment efficacy and increasing the long-term efficacy of psychedelic sessions. About Cybin.

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Clinical Trials Research and Development Treatment Conditions 52

Cannabis Law Report

JULY 24, 2021

“The groundbreaking progress that we’ve seen from the Multidisciplinary Association for Psychedelic Studies (MAPS) in its Phase 3 clinical trials of MDMA-assisted psychotherapy for Post-Traumatic Stress Disorder (PTSD), including receiving Breakthrough Therapy Designation from the Food and Drug Administration (FDA), shows great promise to date.

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Research and Development Clinical Trials Therapy Events 105

Cannabis Law Report

AUGUST 12, 2021

Highlights: Phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression (TRD) close to completion; on track to report data by end of 2021. This is the largest trial ever conducted in psilocybin therapy, and it was done amid the lockdowns and challenges of the COVID pandemic. million, or $0.79 million, or $2.61

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Clinical Trials Therapy Research and Development Data 98

Cannabis Law Report

JULY 29, 2021

Food and Drug Administration for Generally Recognized as Safe (GRAS) is being pursued. GRAS status will allow for the broad application of this novel ingredient in foods as well as dietary supplements. PCT/CA2021/050886, with a filing date of June 28, 2021. Through the Tetra partnership with Thorne HealthTech, a submission to the U.S.

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Research and Development Clinical Trials Events Cannabinoids 105

Cannabis Law Report

OCTOBER 9, 2021

As traditional treatment has proven inadequate at both the individual and public health level, the Commonwealth has a responsibility to research alternative options. Please join us in cosponsoring this legislation, thank you.

Therapy 52

Therapy Clinical Trials Treatment Legislation 52

Cannabis Law Report

JANUARY 24, 2022

Company is on track to announce interim data in mid-2022 from its Phase 2 clinical trial for lead kidney precision medicine product candidate GFB-887. In 2022, we anticipate reading out interim data from our ongoing Phase 2 clinical trial of GFB-887, as well as initial data from our ongoing Phase 1 study of GFB-024.

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Clinical Trials Research and Development Data Medicine 52

The Blunt Truth

AUGUST 13, 2019

Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last week , “the CBD craze is getting out of hand. The FDA has provided clarity that hulled hemp seed, hemp protein powder, and hemp seed oil can be legally used in foods. CBD is “thriving” in the current regulatory environment, but is it doing so illegally?

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CBD Food Seed-To-Sale Wellness and Beauty 80

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. TIMES (Nov.

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Research and Development Therapy Law Clinical Trials 52

Cannabis Law Report

MAY 29, 2022

Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) urging both agencies to advance research on the therapeutic effects of psychedelic drugs. [1] Clinical Trials and Human Subject Protections. Zachary Fuchs.

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Research and Development DEA Clinical Trials Therapy 52

Cannabis Law Report

NOVEMBER 16, 2021

(Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced today that it has received U.S. The secondary measures will be the safety, tolerability, and pharmacokinetics in this population of patients. Chapman continued.

Pharmaceutical 52

Pharmaceutical Clinical Trials Research and Development Therapy 52

The Cannigma

JUNE 15, 2021

The first clinical research done on CBD as a potential treatment for epilepsy was in 1980, but the information gleaned didn’t make its way to the public eye until decades later. CBG, however, also has some medicinal potential that CBD doesn’t, for instance as a treatment for hypertension and insulin resistance. Shutterstock).

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CBD Research and Development Epilepsy Extraction 122

Cannabis Law Report

JULY 9, 2021

Not only are more and more jurisdictions decriminalizing the use of psychedelics for recreational purposes, but it appears that psychedelic substances are the new horizon for the treatment of severe psychological disorders and other ailments. Food and Drug Administration (Aug. Id ; 21 CFR 312.1-10; 10; 312.80-88; 88; 312.300 et seq.

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Law Therapy Clinical Trials Research and Development 105

Veriheal

APRIL 11, 2022

Food and Drug Administration (FDA) when offered in pill form to cancer chemotherapy patients, as well as people who endure appetite loss and/or wasting syndrome caused by AIDS. Additionally, numerous other cannabis-based medications have already gained approval or are in the process of being tested in clinical trials.

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Pharmaceutical Research and Development DEA Clinical Trials 104

Cannabis Law Report

NOVEMBER 9, 2021

As an institution dedicated to diagnosing and treating serious blood diseases and with the ability to pursue investigational medicines from development to manufacture and clinical trial for patients who have exhausted all approved treatment options, having a cost-effective and rapid production chain is integral to ÚHKT’s mission.

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Clinical Trials Research and Development Therapy Supply Chain 52

Cannabis Law Report

DECEMBER 2, 2021

Safety, Ethics and Responsibilities of a Psilocybin Facilitator (10 Hours). Psilocybin Pharmacology, Neuroscience, and Clinical Research (12 Hours). Diversity, Cultural and Health Equity, and Racial Justice and Inclusion in relation to Psilocybin Services (12 Hours). Core Psilocybin Facilitation Skills (16 Hours).

Law 52

Law Programs Therapy Education 52

The Joint Blog

JANUARY 12, 2020

Passage of the 2018 Farm Bill, which eased federal legal restrictions on hemp cultivation and transport, unleashed a stampede of companies rushing products to the market in an absence of regulations ensuring safety, quality and effectiveness. Still, scientific documentation of CBD’s safety and efficacy is nearly nonexistent.

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Pets CBD Clinical Trials Research and Development 36

SpeedWeed

MARCH 18, 2021

Preliminary results from a long-awaited study indicate that cannabis appears to be a safe and well-tolerated treatment for patients managing post-traumatic stress disorder (PTSD), although researchers did not find strong signals of effectiveness. for the production of cannabis used in federally-regulated clinical trials.

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Clinical Trials THC Strains Cannabis 40

Cannabis Law Report

JULY 4, 2021

Clinical trials across the EU have also shown CBD oils and other hemp products to have a potential range of benefits. The Cannabis Trade Association works to improve and maintain health, safety and environmental regulations and practices around cannabis industries. Now we come to CBD.

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THC CBD Legalization Oil 105

Veriheal

MAY 16, 2022

Researchers working at the University of Arizona College of Medicine in Tucson have refined a method of ketamine use in the treatment of Parkinson’s disease (PD). Specifically, the group focused on ketamine’s ability to relieve the side effects of a common treatment called Levodopa. As many as 250 clinics across the U.S.

Research and Development 19

Research and Development Treatment Clinical Trials Patients 19

Cannabis Law Report

SEPTEMBER 24, 2019

Some parents, who have travelled to the Netherlands to buy cannabis medicines, feel the treatment will not help many children because it does not contain THC, which they argue has helped their children. These treatments can be prescribed only by specialist doctors in a limited number of circumstances where other medicines have failed.

Pharmaceutical 55

Pharmaceutical Epilepsy Research and Development Medicine 55

Cannabis Law Report

JULY 24, 2019

Food and Drug Administration sent a warning letter to the company for selling CBD-based products that claim to treat serious diseases. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. July 22, 2019.

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CBD Tincture Pets Chronic Pain 51

The Joint Blog

JULY 25, 2020

organic food market by 2025 is at $70.4 FDA is the government agency that ensures the safety and quality of foods, drugs, cosmetics, and other like products marketed in the United States. CBD Legal and Safety Issues An FDA report presented to the U.S. It has been predicted that the U.S CBD Products and the FDA The U.S.

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CBD Clinical Trials Safety Media 33

Cannabis Law Report

JULY 23, 2019

Maryland’s consumer protection laws along with elements of the Federal Food, Drug and Cosmetic Act can help businesses better understand the requirements for making health claims while marketing medical cannabis products. Some states require mandatory warning statements in advertisements for medical cannabis. Conclusion.

Law 40

Law Clinical Trials CBD Edibles 40

Veriheal

JUNE 29, 2022

Psilocybin , a psychedelic compound found in a variety of mushrooms, has long been used as a tool to mitigate depression despite the limited amount of research on its efficacy and safety. Exploring Psilocybin and Treatment-Resistant Depression. Future Trials With COMP360 Psilocybin. Dr. David J.

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Clinical Trials Blood Pressure Treatment Therapy 103

Project CBD

FEBRUARY 28, 2023

Under section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act — in what some refer to as the “drug preclusion clause” 4 — any substance that is an active ingredient in an approved drug product, or that is being publicly investigated as such, is excluded from the definition of a legal dietary supplement ingredient. 2021;56:530-543.

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CBD Seed-To-Sale Food Access 144

Cannabis Law Report

SEPTEMBER 3, 2019

The laws allow concentrate-based medical cannabis to be prescribed in Australia for the treatment of a variety of specific illnesses. Federal legislation to enable the production and sale of cannabis for medical use and related research purposes was passed by Australia’s parliament in 2016. Australian Leadership Appointments.

Pharmaceutical 45

Pharmaceutical Extraction Research and Development Supply Chain 45

Canna Law Blog

NOVEMBER 6, 2021

To acknowledge its impressive safety record and potential for treating depression more effectively than existing therapies, the Food and Drug Administration designated psilocybin a breakthrough therapy in 2018 and 2019 for treating drug-resistant depression and major depressive disorder. Last week in Nature Medicine , I.

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Clinical Trials DEA Research and Development Therapy 98

Cannabis Law Report

SEPTEMBER 28, 2021

DUBLIN–(BUSINESS WIRE)–The “Epilepsy – Pipeline Insight, 2021” clinical trials has been added to ResearchAndMarkets.com’s offering. It covers the pipeline drug profiles, including clinical and nonclinical stage products. Epilepsy Emerging Drugs. GWP42003-P: GW Research. With the U.S.

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Epilepsy Clinical Trials Research and Development Pharmaceutical 52

CannaMD

MARCH 8, 2021

Food & Drug Association’s role in H.B. Prohibiting a medical marijuana treatment center from dispensing marijuana that exceeds a certain potency of tetrahydrocannabinol [p. Revising a provision relating to the potency of tetrahydrocannabinol in edibles dispensed by a medical marijuana treatment center [p.1,

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THC Research and Development Treatment Patients 116

Cannabis Law Report

OCTOBER 26, 2019

The TG Act also applies to foods, cosmetics, chemicals and general consumer products in respect of which therapeutic claims are made. One such circumstance is a clinical trial. A clinical trial in Australia must have an Australian sponsor (whether it be an individual (e.g.,

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Clinical Trials Medicine Research and Development Compliance 45

Canna Law Blog

MARCH 4, 2020

From 2015 to 2018, the number of clinics increased from 60 to 300; that number is undoubtedly higher today. People are increasingly using ketamine for ailments that resist treatment through traditional pharmaceutical drugs. Food and Drug Administration (FDA) to cities and counties. What are the exact legalities behind ketamine?

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Therapy Legalization Chronic Pain DEA 90

Canna Law Blog

MARCH 4, 2020

From 2015 to 2018, the number of clinics increased from 60 to 300; that number is undoubtedly higher today. People are increasingly using ketamine for ailments that resist treatment through traditional pharmaceutical drugs. Food and Drug Administration (FDA) to cities and counties. What are the exact legalities behind ketamine?

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Legalization Therapy Chronic Pain DEA 52