News & Insights
Understanding the FDA’s New Guidelines for Psychedelic Drug Development and Research
The Food and Drug Administration (FDA) released draft guidance for researchers to consider when conducting clinical trials of the therapeutic benefits of psychedelic drugs.
Australia Authorizes Therapeutic Access to MDMA and Psilocybin
On February 3, 2023, Australia’s Therapeutic Goods Administration (ATGA), a medical authority under the Department of Health and Aged Care, announced a change to the country’s regulatory classification of psilocybin and methylenedioxymethamphetamine (MDMA), allowing the compounds to be prescribed by psychiatrists for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively. The decision was made after the government determined that there was sufficient medical and scientific evidence to support the conclusion that the substances will be beneficial for these conditions. This dramatic change makes Australia the first major country to legalize the therapeutic use of these substances.