Behavioral Health Business July 10, 2023
The FDA is looking to hammer out a new pathway for studying the use of psychedelic drugs to treat behavioral health conditions.
Specifically, the agency recently released a new draft guidance for the clinical development of psychedelic drugs.
Although psychedelic drugs have shown promise in treating various mental health and substance use disorders, researchers have faced barriers in setting up clinical studies to evaluate the substances. In turn, providers have been limited in the use of these drugs to treat patients.
These draft guidelines outline the consideration for drug development programs, clinical trials and marketing authorizations, plus safety and abuse protocols.
In the guidance, the FDA noted that psychedelic research has several nuances that must be considered.
“Some drug development...
Today's Sponsors
Today's Sponsor