IND (Investigational New Drug)
An application submitted to the FDA allowing a pharmaceutical company or researcher to begin clinical trials of an unapproved drug in humans.
In Depth
An IND application must include preclinical data, manufacturing information, clinical protocols, and investigator qualifications. For cannabis research, INDs must also address DEA Schedule I requirements. The FDA has granted INDs for cannabinoid research including the trials that led to Epidiolex approval. Researchers studying whole-plant cannabis face additional hurdles compared to those studying isolated cannabinoids.
Related Terms
Further Reading
More in Regulatory
Schedule I
The most restrictive classification under the US Controlled Substances Act (CSA), applied to substances deemed to have high abuse potential, no accepted medical use, and lack of accepted safety under medical supervision.
NCT Number
A unique identifier assigned by ClinicalTrials.gov to every registered clinical study. Format: NCT followed by 8 digits (e.g., NCT04849910).
GMP (Good Manufacturing Practice)
A system of regulations ensuring that products are consistently produced and controlled according to quality standards. Required for pharmaceutical-grade cannabinoid products.
DEA (Drug Enforcement Administration)
The US federal agency responsible for enforcing controlled substances laws. Administers the scheduling system under the Controlled Substances Act.
FDA (Food and Drug Administration)
The US federal agency responsible for regulating drugs, biologics, medical devices, and food. Has approved three cannabinoid-based drugs: Epidiolex, Marinol (dronabinol), and Cesamet (nabilone).