- FDA Regulation and Quality Considerations for Cannabis and ...🔍
- FDA Regulation of Cannabis and Cannabis|Derived Products🔍
- Quality Considerations for Clinical Research Guidance for Industry🔍
- FDA and Cannabis🔍
- Audio Transcript🔍
- Cannabis and Cannabis|Derived Compounds🔍
- Quality Considerations for Clinical Research🔍
- FDA Regulation and Quality Considerations for Cannabis ...🔍
FDA Regulation and Quality Considerations for Cannabis and ...
FDA Regulation and Quality Considerations for Cannabis and ...
Sources of Cannabis: Both sources of cannabis defined as hemp and those containing >0.3% delta-9 THC on a dry weight basis may be used for ...
FDA Regulation of Cannabis and Cannabis-Derived Products
Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug ...
Quality Considerations for Clinical Research Guidance for Industry
This guidance outlines FDA's current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis.
FDA and Cannabis: Research and Drug Approval Process
The FDA also has issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” ...
Audio Transcript | FDA Regulation and Quality Considerations for ...
Today's topic: FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds. There is increasing interest in the ...
Cannabis and Cannabis-Derived Compounds: Quality ...
... Compounds: Quality Considerations for Clinical Research." This guidance outlines FDA's current thinking on several topics relevant to the...
the CSA of the cannabis or cannabis-derived materials (e.g., botanical raw materials, drug substances, and drug products) and applicable DEA regulatory ...
FDA Regulation and Quality Considerations for Cannabis ... - YouTube
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds.
FDA Issues Final Guidance on Quality Considerations for Clinical ...
Noting that cannabis and cannabis-derived compounds are held to the same regulatory standards as botanical raw materials, drug substances, or ...
Resources for Information on Quality Considerations ... same authorities and requirements, including quality standards, as FDA-regulated drug products.
FDA Issues Long-Awaited Draft Guidance on Cannabis Research
On July 21, 2020, the US Food and Drug Administration (FDA) issued a long-awaited draft guidance, “Cannabis and Cannabis-Derived Compounds: ...
preserved by the Farm Bill. • Cannabis and cannabis-derived products are subject to the same authorities and requirements as FDA-regulated products containing ...
Draft Guidance for Industry; Availability - Regulations.gov
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability.
FDA's Guidance on Quality Considerations for Clinical Research ...
The guidance does not address development of fully synthetic substances, sometimes known as cannabis-related compounds, which are regulated like ...
… topic: FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds. There is increasing interest in the potential utility of ...
The Surprising Reach of FDA Regulation of Cannabis, Even After ...
The FDA's focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent with the “entourage ...
FDA issues Draft Guidance on Cannabis and Cannabis-Derived ...
FDA issues Draft Guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research · See the guidance and file ...
FDA, USP Advance Standardization, Regulation of Cannabis ...
The US Pharmacopeial Convention (USP) is championing cannabis quality standards with a new cannabis monograph that recently closed for public comment.
Quality Considerations for Clinical Research. • Cannabis and cannabis ... – Engagement with stakeholders on CBD issues. – FDA's CBD ...
FDA Releases Final Guidance on Quality Considerations for ...
The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research ...