Cannabis and cannabis-derived compounds: quality considerations for clinical research : guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Cannabis Drug Development Government Regulation Medical Marijuana United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- 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. Cannabis and cannabis-derived compounds that may be used in manufacturing human drugs include botanical raw materials, extracts, and highly purified substances of botanical origin. This guidance provides recommendations for sponsors interested in developing such cannabis and cannabis-derived compounds for use in human drugs for clinical research. This guidance does not address development of fully synthetic versions of substances that occur in cannabis, sometimes known as cannabis-related compounds (e.g., dronabinol), which are regulated like other fully synthetic drugs. This guidance is limited to the development of drugs for human use and does not cover other FDA-regulated products. This guidance addresses the legal definitions and regulatory controls related to cannabis (see section II), and it addresses certain questions raised in a public hearing about drugs containing cannabis and cannabis-derived compounds. The guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with FDA or our authorities than other drug developers. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (10 pages))
- NLM Unique ID:
- 9918590888106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918590888106676