On January 15, 2025, MAPS submitted to the FDA the 2024 Cannabis Data Safety Update Report (DSUR) along with a protocol amendment. The DSUR serves as the FDA Annual Report on the progress of the drug …
On November 7, 2024, MAPS received notice from the FDA that the Phase 2 study of Cannabis for Veterans with PTSD (MJP2) is cleared to proceed with smoking as a delivery method. This update confirms that …
On October 10, 2024, MAPS submitted a Complete Response to FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). This response addressed the four key clinical hold issues identified …
On September 19, 2024, MAPS received the response from the Office of Neuroscience to the Formal Dispute Resolution Request (FDRR) submitted by MAPS on August 23, 2024. The FDRR was submitted in response …
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 …
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. …