The FDA is considering new methods to evaluate psychedelic-assisted therapies for mental health conditions, including changes to study design, administration and long-term monitoring.

The FDA is signalling openness to novel approaches for assessing psychedelics including psilocybin, MDMA, LSD, DMT and ketamine. Potential changes could address study design, administration methods and long-term monitoring as regulators consider treatments for major depressive disorder and PTSD.