NORML

JANUARY 4, 2019

Happy New Year and welcome to the first Weekly Legislative Roundup of 2019! The new Congress was just sworn in yesterday, and they are not wasting any time. At the state level, Alaska regulators have voted in favor of plans to permit on-site marijuana consumption at designated retailers.

Legislation 128

Legislation Clinical Trials Research and Development Access 128

Cannabis Law Report

AUGUST 21, 2019

However, health professionals have been reluctant to prescribe cannabis-based medicines in the UK because of the lack of clinical trial evidence of its benefits and safety. This would answer questions about safety and efficacy, they said. The final guideline is expected to be published in November 2019.

Clinical Trials 81

Clinical Trials Nerve Pain Medicine Epilepsy 81

Cannabis Law Report

FEBRUARY 28, 2022

Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. 12, 2019), [link] [ [link] ]. 1025, 1026 (2021) (reporting significant improvement of PTSD symptoms following treatment with MDMA in clinical trial); see also Alec J. Mitchell et al.,

Research and Development 52

Research and Development Therapy Law Clinical Trials 52

The Blunt Truth

AUGUST 13, 2019

In March of 2019, the FDA established a Working Group to determine the possible legislative pathways to regulate CBD. On May 31, 2019, the FDA’s Working Group held a public hearing for stakeholders to share their experiences and challenges with CBD products, including information and views related to product safety.

CBD 80

CBD Food Seed-To-Sale Wellness and Beauty 80

Cannabis Law Report

JULY 9, 2021

Denver, Colorado was the first jurisdiction to decriminalize the use of psilocybin via ballot initiative in May 2019. 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.

Law 105

Law Therapy Clinical Trials Research and Development 105

SpeedWeed

JULY 6, 2021

The Project on Psychedelics Law and Regulation (POPLAR) is a three-year project aiming to “promote safety, innovation, and equity in psychedelics research, commerce, and therapeutics,” the university said in a press release. Several prestigious American universities have launched their own psychedelics centers in the past decade.

Policy 52

Policy Law Research and Development Therapy 52

Cannabis Law Report

MAY 29, 2022

In May 2019, Denver became the first city to decriminalize psilocybin, followed by Oakland, CA, Washington, D.C., In 2019, FDA approved Spravato (esketamine) nasal spray for treatment of depression in adults. [8] Clinical Trials and Human Subject Protections. 5, 2019), [link]. [9] Recent Regulatory Developments.

Research and Development 52

Research and Development DEA Clinical Trials Therapy 52

Cannabis Law Report

JUNE 10, 2021

The Traffic Safety Culture Index is an annual survey with national scope and multiple measures relevant to driving after marijuana use. Because THC presence is an imperfect proxy for impairment [ 10 ], driving data may be limited in clarifying what traffic safety risks, if any, are associated with permissive marijuana policies.

Policy 59

Policy Safety Marijuana Data 59

MedicalJane

MAY 21, 2020

Researchers at The University of New Mexico (UNM) have conducted a series of recent studies testing the effectiveness and safety of consuming cannabis, but this is the first study they have conducted measuring the therapeutic potential of hemp oil with low THC levels. The Hemp Farming Act of 2018.

Oil 100

Oil Hemp Extraction Clinical Trials 100

Cannabis Law Report

JUNE 25, 2021

In April 2019, Bristol-Myers Squibb acquired Celgene for $74 billion. The European Medicines Agency (EMA) is the regulatory body that evaluates and supervises the production and sales of medicines for safety and benefit of the customer, in the European Union Region. Examples of skin cancer drug include 5-FU, Aldara and Efudex.

Research and Development 84

Research and Development Therapy Pharmaceutical Clinical Trials 84

Cannabis Law Report

NOVEMBER 16, 2021

For multiple health and safety reasons, we believe orally dosed MYMD-1 is vastly superior to any of the available TNF inhibitors on the market today, one of which is the best-selling drug in the world.”. 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

Cannabis Law Report

OCTOBER 9, 2021

Indeed, studies conducted by world renowned medical institutions indicate that psilocybin has shown efficacy, tolerability, and safety in the treatment of conditions including but not limited to addiction, depression, anxiety disorders, and end-of-life psychological distress. Please join us in cosponsoring this legislation, thank you.

Therapy 52

Therapy Clinical Trials Treatment Legislation 52

The Joint Blog

JANUARY 23, 2020

” The systematic review of the literature “was conducted during 2019, assessing the data from all case studies and clinical trials involving medicinal cannabis or plant-derived isolates for all major psychiatric disorders (neurological conditions and pain were omitted).”

Clinical Trials 52

Clinical Trials Sleep Marijuana Cannabinoids 52

The Cannigma

AUGUST 31, 2021

The researchers stated that these knowledge gaps must be addressed and that “clinical trial data about how medical cannabis improves patient quality of life domains is desperately needed as this information can impact clinical decision-making.”. People want to trust their doctors, but doctors need knowledge” (Shutterstock).

Education 101

Education Clinical Trials Medicine Policy 101

Cannabis Law Report

AUGUST 19, 2019

To obtain registration, a drug sponsor is generally required to run large-scale clinical trials proving safety and efficacy and provide the resulting evidence to the TGA. In Australia, drugs that doctors prescribe conventionally have obtained ‘registration’ with the TGA.

Medicine 45

Medicine Patients Clinical Trials Access 45

The Cannigma

JULY 1, 2022

The highest quality form of scientific research, in terms of whether the results provide predictive power (which is what science is all about), is the placebo controlled, double blind, randomized clinical trial. Non-clinical research can help answer questions regarding safety and risk in very powerful ways.

Research and Development 108

Research and Development Data THC Clinical Trials 108

The Cannigma

AUGUST 26, 2021

A major move in the direction of legalization took place in September 2019, when the Australian Capital Territory legalized cannabis possession (up to 50 grams) and the cultivation of up to two cannabis plants. This also means that the TGA has not accessed these medicines for their safety, quality, or effectiveness.

Legalization 52

Legalization Access Medicine Clinical Trials 52

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.

THC 105

THC CBD Legalization Oil 105

Cannabis Law Report

SEPTEMBER 3, 2019

Awarded Australian Cannabis Industry 2019 Innovation Award. 03, 2019 (GLOBE NEWSWIRE) — MediPharm Labs Corp. Construction of MediPharm Labs Australia’s extraction and manufacturing facility in Wonthaggi, Victoria is progressing very well with completion on target before year-end 2019. BARRIE, Ontario, Sept.

Pharmaceutical 45

Pharmaceutical Extraction Research and Development Supply Chain 45

Cannabis Law Report

NOVEMBER 24, 2019

NICE guideline [NG144] Published date: November 2019. Do not offer CBD to manage chronic pain in adults unless as part of a clinical trial. the person’s clinical condition is stable. 1 ] November 2019. [ Cannabis-based medicinal products. Tools and resources. Recommendations. Recommendations for research.

Medicine 59

Medicine Chronic Pain Research and Development Treatment 59

Cannabis Law Report

SEPTEMBER 24, 2019

September 23, 2019. We are very happy that patients will now have access to a much-needed, new treatment option, and one routed through a rigorous clinical trials programme and licensed by the EMA.”. PDF Version. LONDON and CARLSBAD, Calif.,

Pharmaceutical 55

Pharmaceutical Epilepsy Research and Development Medicine 55

Cannabis Law Report

JULY 23, 2019

In April 2019 Thurston filed a class action lawsuit in California against Koi CBD, suing it for violations of California State Unfair Competition and Consumer Legal Remedies Laws and the Pennsylvania Unfair Trade Practices and Consumer Protection Law. She lost her job as a result.

Law 40

Law Clinical Trials CBD Edibles 40

Cannabis Law Report

JUNE 4, 2021

It seems completely backwards that an unregulated product that gets people “high” and is synthesized in a lab can be sold at gas stations and smoke shops but naturally derived Delta 9-THC must go through rigorous safety testing and can only be sold and handled by licensed companies.

Research and Development 105

Research and Development Seed-To-Sale Cannabinoids THC 105

Healer

DECEMBER 17, 2021

The safety profile of CBD has been acknowledged by major health agencies, such as the World Health Organization (WHO), showing that it’s well-tolerated by animals and humans and rarely produces any dangerous side effects. Numerous studies have shown that CBD is a safe, non-impairing, and non-habit-forming substance. 2014): 86-95. Medicines 6.1

CBD 98

CBD THC Conditions Medicine 98

Cannabis Law Report

JANUARY 11, 2019

However, we firmly disagree that the referenced clinical trials are in fact “substantial,” as the trials were extremely limited in scope, and funding and the publication of these trials were limited. CBD has been found to be generally well tolerated with a good safety profile.”.

Hemp 49

Hemp CBD Law Seed-To-Sale 49

Puff Puff Post

NOVEMBER 5, 2019

5, 2019 /CNW/ – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (TSX: IN; OTCQX: IMLFF), today announced the filing of a Clinical Trial Application (“CTA”) in the Netherlands to initiate a Phase 1 human clinical trial for INM-755 in healthy volunteers. Adams, CEO.

Clinical Trials 40

Clinical Trials Pharmaceutical Cannabinoids Data 40

TheAnswerPage

JANUARY 11, 2022

For example, most, if not all, states have legalized the use of medical marijuana to treat specific health conditions for which there is no or only poor quality clinical evidence of efficacy and safety. Published 2019 May 6. Gardiner KM, Singleton JA, Sheridan J, Kyle GJ, Nissen LM. 2019;14(5):e0216556. doi:10.1371/journal.pone.0216556.

Patients 98

Patients Education Marijuana Therapy 98

Cannabis Law Report

JULY 24, 2019

July 22, 2019. Examples of claims observed on your website and social media accounts in April 2019 that establish the intended use of your products as drugs include, but may not be limited to, the following: On your product webpage for CBD Disposable Vape Pen (Relieve): • “[F]or chronic pain.”. RETURN RECEIPT REQUESTED. Curaleaf, Inc.

CBD 51

CBD Tincture Pets Chronic Pain 51

Cannabis Law Report

JULY 21, 2022

Patient safety concerns uncovered during an ongoing federal review have led to the suspension of one of two clinical trials for MDMA-assisted psychotherapy currently underway in Canada. A spokesperson told CBC in an email that the study was put on hold “due to concerns for participant safety.” CBC Canada.

Safety 52

Safety Patients Clinical Trials Data 52

Canna Law Blog

APRIL 17, 2020

When it comes to CBD the, research is limited but a small clinical trial at Colorado State University found that CBD oil reduced seizures in epileptic dogs meaning that it may have similar effects as found in humans. However, stakeholders still need to establish the safety of these products with AAFCO and the FDA.

Pets 58

Pets Hemp CBD Food 58

Healer

DECEMBER 17, 2021

The safety profile of CBD has been acknowledged by major health agencies, such as the World Health Organization (WHO), showing that it’s well-tolerated by animals and humans and rarely produces any dangerous side effects. 2019): 3. [3] Numerous studies have shown that CBD is a safe, non-impairing, and non-habit-forming substance.

CBD 52

CBD THC Conditions Medicine 52

The Cannigma

JUNE 15, 2021

In testimony before the Senate in 2019, then-FDA Deputy Commissioner Dr. Amy Abernethy clarified that CBD products may not be marketed as food or food supplements. But the main issue with hemp derived products and their safety is less about the CBD and more about everything else in them. Shutterstock). Kevin McGovern/Shutterstock).

CBD 122

CBD Research and Development Epilepsy Extraction 122

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. For two decades, U.S.

Clinical Trials 98

Clinical Trials DEA Research and Development Therapy 98

Cannabis Law Report

OCTOBER 26, 2019

One such circumstance is a clinical trial. A clinical trial in Australia must have an Australian sponsor (whether it be an individual (e.g., Two of the avenues for supply of UTGs for clinical trials are the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme.

Clinical Trials 45

Clinical Trials Medicine Research and Development Compliance 45

The Joint Blog

APRIL 21, 2020

This is according to a study published in the Journal of Clinical Medicine Research and epublished by the U.S. For the study researchers with the Nordic Cannabis Research Institute in Denmark reviewed 25 clinical trials assessing the safety and efficacy of CBD in various populations. National Institute of Health.

Clinical Trials 52

Clinical Trials CBD Safety Patients 52

Cannabis Law Report

AUGUST 30, 2019

Americans for Safe Access released its 2018-2019 State-of-the-State report examining state laws and regulations surrounding Patient Rights and Civil Protection from Discrimination, Access to Medicine, Ease of Navigation, Functionality of the Programs, and Consumer Safety and Provider Requirements. Medical/Health.

Banking 45

Banking Research and Development Legislation Programs 45

Project CBD

FEBRUARY 28, 2023

Sales appear to have peaked in 2019, when natural channel consumers spent more than $90.7 Despite the companies’ submitting the required data demonstrating the “reasonable expectation of safety under the recommended conditions of use,” the FDA rejected the applications, citing the drug preclusion clause. million on these products.

CBD 144

CBD Seed-To-Sale Food Access 144