Both bills prevent researchers from obtaining marijuana products from state dispensaries or growers.
WEST, RI /ACCESSWIRE /August 1, 2022/ MMJ International Holdings, MMJ BioPharma Labs and MMJ BioPharma Culture the Prime Minister medical cannabis research companies announced that it has completed FDA-required manufacturing of its proprietary THC and CBD marijuana soft gelatin capsule. MMJ International Holdings has several filings with the FDA in Multiple sclerosis and Huntington’s disease and is developing a non-synthetic oral drug from marijuana plant extracts. MMJ will use its new product for its clinical trials once approved by the FDA.
MMJ had received a DEA import permit its proprietary cannabis extracts in the United States to develop therapies for Huntington’s disease and multiple sclerosis. After considerable work, the team has achieved several milestones in developing its proprietary scientific process for extracting THC, CBD and other ingredients for its drug formulation. MMJ received the FDA coveted orphan awards for Huntington’s disease and MMJ BioPharma Labs has been awarded their registration in the DEA Schedule 1 cannabis testing laboratory.
While MMJ has cooperated with several government agencies including the FDA, DEA, US Customs and Border Protection (CBP), Health Canada and the Center for Drug Evaluation and Research (CDER) , to accomplish his mission more recently, he was forced to file a lawsuit against the DEA for dragging your feet. Duane Boise, President and Founder, said “Unfortunately, we had to file a complaint against the DEA to facilitate a response, however, we are in discussion to clarify any concerns the DEA may have. We are confident that API Bulk Manufacturing registration will be issued soon. The DEA is currently processing the company’s application so that it can proceed with the evaluation and research required by the FDA.
Tim Moynahan, the company’s president, said it was “grossly untrue that the DEA took so long to process our application.” We have been patient since December 2018 waiting for the DEA to act. We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work with the FDA and DEA to close knowledge gaps about the scientific safety and quality of MMJ’s products. We are committed to advancing our product development through an approach consistent with the government’s mission to put public health first, foster innovation and promote consumer confidence.
The DEA said: ” the DEA anticipates that additional strains of marihuana will be produced and made available to researchers. This should make it easier to find advance scientific understanding on the effects of marihuana, and potentially aid in the development of safe and effective drug products that can be approved for marketing by the Food and Drug Administration,”
Dr. Elio Mariani, CEO, said, “MMJ’s clinical trials will provide the FDA with dosing, safety, and patient efficacy data to prove that cannabis can treat the debilitating effects of multiple sclerosis. and Huntington’s disease. MMJ continues its process of scientific drug discovery and development by following FDA development processes and DEA regulatory manufacturing guidelines.
Last week, the US House of Representatives passed a revised bipartisan bill that would make it easier for researchers to study marijuana. The bill passed Tuesday by a resounding vote of 325 to 95. The Medical Marijuana and Cannabidiol Research Act, or HR 8454now goes to the Senate, where it should pass.
Both bills prevent researchers from obtaining marijuana products from state dispensaries or growers.
Researchers can only obtain products for research from DEA-approved Schedule 1 registrants.
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THE SOURCE: MMJ International Holdings
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