• The U.S. Food and Drug Administration has published a draft guidance document that details the agency’s current thinking about how drug developers can perform compliant clinical research when developing new drugs containing cannabis or cannabis-derived compounds.
  • This guidance is meant to clarify the agency’s approach to reviewing human clinical trial applications involving drugs that contain cannabis, given the 2018 Farm Bill’s change to the control status of hemp. The FDA’s document provides drug developers with recommendations regarding new potential options to source cannabis and cannabis-derived compounds for drug development, highlights informational resources for stakeholders to review to ensure quality considerations are being met, and indicates how and when percent delta-9 tetrahydrocannabinol (THC) calculations should be performed.
  • The FDA’s publication makes it clear that, when performing clinical research, sponsors and investigators of clinical studies can utilize hemp that does not exceed a 0.3 percent delta-9 THC limit as a source of cannabis and cannabis-derived compounds. This constitutes a significant expansion of accessibility to those looking to develop drugs with cannabis and cannabis-derived compounds for appropriate medical applications. In releasing such guidance, the agency affirms its support of the development of these new drugs that satisfy the necessary review and approval processes. This draft guidance is open for comment submission until September 21, 2020.