FEDERAL and STATE GUIDELINES
The CMCR directors and staff are available to assist you with your proposal and application process.
Once proposals have been rated by the external Scientific Review Board of experts, investigators will be notified of approved proposals. All CMCR studies will be expected to meet State and Federal Regulatory Guidelines.
A guideline is available for both Clinical Trials and Pre-Clinical Studies here on our website that outline the federal and state regulatory steps. The guidelines also include our anticipated dates for submission to these various regulatory agencies.
For investigators who would like to examine in greater detail the regulations governing the use of an investigational new drug, specifically a Schedule I substance such as Cannabis, the following links may be useful:
Research Advisory Panel of California
DEA Regulations Title 21, Part 1300 (Controlled Substances)
FDA Regulations Title 21, Part 312 (IND Application)
