MMJ BioPharma说, 缉毒局的许可证规则阻止其符合FDA的Huntington和MS大麻药物研发,
MMJ BioPharma says DEA licensing rules block its FDA-compliant cannabis drug development for Huntington’s and MS, stalling U.S. medical innovation.
开发符合FDA的用于亨廷顿病和多发性硬化症的大麻药物的MMJ BioPharma Cultivation表示,DEA的许可程序创造了一个不可能的监管循环,在批量生产批准之前需要买方协议,尽管通过了检查并持有孤儿药物指定.
MMJ BioPharma Cultivation, developing FDA-compliant cannabis medicines for Huntington’s disease and multiple sclerosis trials, says the DEA’s licensing process creates an impossible regulatory loop, requiring a buyer agreement before bulk manufacturing approval, despite passing inspections and holding Orphan Drug Designations.
该公司认为这一矛盾阻碍合法研究、扼杀创新、推动医疗海外进步, 其首席执行官和法律团队敦促联邦改革,
The company argues this contradiction blocks lawful research, stifles innovation, and pushes medical advancements overseas, with its CEO and legal team urging federal reform amid growing congressional and judicial scrutiny over the system’s impact on patient access and U.S. leadership in cannabinoid therapeutics.