On August 23, 2024, MAPS submitted a Formal Dispute Resolution Request to appeal the Clinical Hold placed on the Phase 2 study of cannabis for Veterans with PTSD (MJP2) by the FDA Division of Psychiatry …
FOR IMMEDIATE RELEASE: August 9, 2024 Aug 9, 2024 – San Jose, CA – The Multidisciplinary Association for Psychedelic Studies (MAPS) is evaluating the path forward for safe, legal access to MDMA-assisted …
On January 11, 2024, MAPS submitted to the FDA the 2023 Cannabis Data Safety Update Report (DSUR). The DSUR serves as the FDA Annual Report on the progress of the drug investigation over the last year. …
On December 28, 2023, the FDA Informed MAPS that the Partial Clinical Hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) would be continued. This Clinical Hold letter rejects the …
MAPS’ proposed Study MJP2 study is a research study that is intended to add to the cannabis safety literature and contribute to a better understanding of the safety and effectiveness of real-world …
On August 11, the FDA Division of Pulmonology, Allergy, and Critical Care (DPACC) sent MAPS additional guidance on the safety of smoking in naïve subjects in MJP2. The FDA’s correspondence was a …
On July 12, 2023, the FDA Division of Psychiatry sent MAPS the official minutes of our Type A meeting on June 15, 2023. The Type A meeting focused on the issues the FDA cited in its Clinical Hold on the …
After reviewing MAPS’ Type A Meeting Request and Briefing submitted on April 28, the FDA granted MAPS’ meeting request. MAPS and the FDA will have a face-to-face formal meeting to discuss the …
On April 28, 2023, MAPS requested the FDA for a Type A meeting to discuss the clinical hold issues for Study MJP2 in order to overcome the clinical hold deficiencies. This meeting request is in response …
On March 14, 2023, MAPS released a progress report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Read the Q4 2022 progress report here.
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 …
On December 16, 2022, the FDA advised MAPS that the Partial Clinical Hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) would be continued due to “insufficient information …
