Senators Wyden, Merkley Urge FDA To Update Regulations To Ensure US Producers & Consumers Have Access To CBD, Other Hemp Products

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DISTRICT OF COLUMBIA: Senators Ron Wyden and Jeff Merkley today urged the U.S. Food and Drug Administration (FDA) to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements. Congress legalized the production and sale of industrial hemp and hemp derivatives, including hemp-derived cannabidiol (CBD), when it passed Wyden Read the full article…

Farm Bill Provisions Lifting Federal Hemp Ban Become Law

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DISTRICT OF COLUMBIA: President Donald Trump today signed legislation into law that includes language lifting the United States’ decades-long prohibition on domestic, commercial hemp production. The provisions were included within The Agriculture Improvement Act of 2018 (aka ‘The Farm Bill’), which takes effect on January 1, 2019. “The significance of this law change should not be underemphasized,” NORML Read the full article…

FDA Statement Statement From FDA Commissioner Scott Gottlieb, On Signing Of The Agriculture Improvement Act And The Agency’s Regulation Of Products Containing Cannabis And Cannabis-derived Compounds

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DISTRICT OF COLUMBIA: Today (December 20, 2018), the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry Read the full article…

NORML Delivers Over 10,000 Public Comments To FDA Regarding International Classification Of Cannabis

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DISTRICT OF COLUMBIA: NORML staffers on Wednesday hand-delivered over 10,000 public comments to the US Food and Drug Administration calling on the agency to recommend amending the substance’s illicit status under international treaties. The agency had requested public comments so that they could be “considered in preparing a response from the United States to the World Health Organization regarding the Read the full article…

FDA Calls for Public Comments Regarding International Classification Of Cannabis

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MARYLAND: The US Food and Drug Administration is seeking public comments specific to whether changes ought to be recommended regarding the international classification of cannabis as a controlled substance. Members of the public have until October 31, 2018 to submit their comments to the FDA for consideration. The FDA says that the comments “will be considered in preparing a response from the Read the full article…

Statement From FDA Commissioner Scott Gottlieb On Researching Medical Uses Of Cannabis

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

By Scott Gottlieb, MD DISTRICT OF COLUMBIA: Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of “medical marijuana” advertised its uses for a wide number of medical conditions, such as cancer, multiple sclerosis, post-traumatic stress disorder and anxiety – just to name Read the full article…

FDA Approves Marketing Of Plant-Derived Marijuana Medicine

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DISTRICT OF COLUMBIA:  Regulators at the US Food and Drug Administration on Monday granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. The proprietary extract formulation – developed by the British biotechnology firm GW Pharmaceuticals – had Read the full article…

FDA Approves First Cannabis-Based Epilepsy Drug

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MARYLAND: The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from Read the full article…

Premier Biotech’s Oral Fluid Drug Testing Device Granted FDA Clearance

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MINNESOTA: On February 2, 2018, Premier Biotech Inc. was granted a coveted 510(k) clearance for the following drugs Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiates and Phencyclidine from the Food and Drug Administration (FDA) for OralTox, its flagship, patented rapid oral fluid drug screen device. A FDA 510(k) clearance is a significant achievement as it paves the Read the full article…

FDA Grants ‘Priority Review’ Of Plant-Derived CBD Extract

If Epidiolex achieves FDA-approval, analysts suggest the product could retail for between $30,000 to $60,000 annually.

DISTRICT OF COLUMBIA: Representatives of the US Food and Drug Administration will undertake a ‘priority review‘ of data specific to the safety and efficacy of Epidiolex, a standardized, plant-derived CBD extract formulated by a British pharmaceutical company. The review is scheduled to be completed by June 27, 2018. Phase III clinical trial data shows that Epidiolex Read the full article…