On January 19, 2023, the FDA advised MAPS that cannabis used in clinical trials is defined as a drug product, rather than a botanical raw material, for the purposes of microbiological testing acceptance criteria. Read the Microbiology Comments here.
The FDA additionally requested protocol modifications related to effect size and one additional CAPS-5 assessment. Read the protocol recommendations here.
MAPS has requested the FDA lift the clinical hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2).
