FDA发布《大麻及大麻衍生成分：临床研究质量考量》最终指南
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
FDA发布《大麻及大麻衍生成分：临床研究质量考量》最终指南，档案编号FDA-2020-D-1079，由药物评价与研究中心（CDER）发布。指南阐述FDA对含大麻或大麻衍生成分的人用药物开发相关临床研究若干议题的当前思考。
材料为FDA最终指南的说明页，可帮助读者了解该指南针对含大麻及大麻衍生成分药物临床研究的适用范围与评议方式。
GUIDANCE DOCUMENT
Final Level 1 Guidance
- Docket Number:
- FDA-2020-D-1079
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds. As defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), drug includes any product that is intended to diagnose, cure, mitigate, prevent, or treat a disease, or any product (other than food) intended to affect the structure or any function of the body. In general, this means any product (including one that contains cannabis or cannabis-derived compounds) marketed with a claim of therapeutic benefit, or with any other disease-related claim, is considered a drug. To be legally marketed in interstate commerce, drugs that are not biological products generally must either (1) receive premarket approval by FDA through the new drug application (NDA) or abbreviated new drug application (ANDA) process, or (2) for certain over-the-counter nonprescription drugs, meet the requirements in the FD&C Act for marketing without an approved NDA or ANDA. The recommendations in this guidance are intended for products that meet the legal definition of a drug under the FD&C Act.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1079.
来源：FDA Pharmaceutical Quality Documents · fda.gov