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FDA Says It Supports Cannabis Drug Development via Regulatory Pathways
JAMA ( IF 120.7 ) Pub Date : 2020-02-18 , DOI: 10.1001/jama.2020.0833
Rebecca Voelker

A key FDA official told members of Congress last month that the agency supports the development of new drugs that contain cannabis or are derived from the plant.

Speaking before the House Committee on Energy and Commerce, Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said investigators interested in conducting cannabis research that could lead to a drug approval need to first submit an investigational new drug (IND) application.

Even though cannabis is among Schedule I substances considered to have a high potential for abuse and no accepted medical value, Throckmorton said these substances can be evaluated in clinical trials as long as sponsors submit an IND and register with the Drug Enforcement Administration.



中文翻译:

FDA表示通过监管途径支持大麻药物开发

FDA的一位重要官员上个月告诉国会议员,该机构支持开发含有大麻或植物来源的新药。

FDA药品评估与研究中心法规计划副主任道格拉斯·Throckmorton医师在众议院能源和商业委员会上发表讲话说,有兴趣进行可能导致药物批准的大麻研究的研究人员需要首先提交研究报告。新药(IND)应用。

尽管大麻属于被认为具有很高的滥用潜力且没有公认的医学价值的附表I物质,但Throckmorton表示,只要发起人提交IND并在药物管制局注册,这些物质就可以在临床试验中进行评估。

更新日期:2020-02-18
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