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 …
On November 16, 2022, MAPS submitted a revised protocol to the FDA in response to hold issues identified in the Agency’s Continued Partial Clinical Hold letters dated May 10 and December 27, 2021. …
On October 15, 2022, MAPS released a progress report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Previous progress reports were released for quarters ending in January, April, and July. …
On August 30, 2022, the FDA responded to MAPS’ request to lift the clinical hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2), citing an incomplete response to the hold. …
