UP-TO-DATE, RESEARCH BASED INFORMATION ABOUT PSYCHEDELICS.
News just out ... the US FDA plans to respond to MAPS/Lykos MDMA licensing application on August 11th
The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024 to make the review determination.
MAPS PBC announces submission of new drug application to the FDA for MDMA-assisted therapy for PTSD
The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively).