The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance. The final guidance follows the passage of the Medical Marijuana and Cannabidiol Research Expansion Act and provides key clarifications on quality requirements for cannabis and cannabis-derived compounds used in clinical research.
Drug sponsors and clinical trial investigators may use hemp, including cannabis and derivatives, in drug research if the FDA deems the cannabis to be of “adequate quality,” which is determined during an investigational new drug (IND) application.
Partner Kathleen Sanzo and associate Alexandre Gapihan discuss the guidance and its consequences in a recent LawFlash.