Tag Archive for: fda
https://psychedelicspotlight.com/wp-content/uploads/2023/11/new-images-PS-1200-×-802-px-2023-11-09T164232.638.png 802 1200 Maria Holyanova https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Maria Holyanova2023-11-09 22:47:112023-11-09 22:47:13FDA Sparks Debate Over the Role of Psychological Support In Psychedelic Clinical Trials
While clinical research furthers its quest in proving psychedelics’ potential in treating a variety of psychiatric disorders, the debate now is the importance of psychological support in trials investigating psychedelic-assisted therapy.
https://psychedelicspotlight.com/wp-content/uploads/2023/09/new-images-PS-1200-×-802-px-30.png 802 1200 Greg Gilman https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Greg Gilman2023-09-14 18:35:492023-09-14 19:28:19MDMA Successfully Treats PTSD in Another Phase 3 Trial Sponsored by MAPS
"MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024," says MAPS founder and president Rick Doblin.
https://psychedelicspotlight.com/wp-content/uploads/2023/06/Policy_ImageryArtboard-3.jpg 875 1310 Phil Dubley https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Phil Dubley2023-06-30 14:57:012023-06-30 14:57:01The Biggest Psychedelic News Stories of the Week – June 30
In yet another eventful week in the psychedelics sphere, more clear signs depict psychedelics’ popularity and acceptance.
https://psychedelicspotlight.com/wp-content/uploads/2023/06/new-images-PS-1200-×-802-px-12.png 802 1200 Maria Holyanova https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Maria Holyanova2023-06-27 14:28:062023-06-27 19:53:41The FDA Issues Guidance on Designing Psychedelic Clinical Trials
The Food and Drug Administration published a new draft guidance with the purpose to advise researchers on study design when investigating the potential of psychedelics.
https://psychedelicspotlight.com/wp-content/uploads/2021/11/FDA_Approves_First_Natural_Psychedelics_Psilocybin_Clinical_Trial_PSychedelic_Spotlight.jpg 874 1310 Emily Jarvie https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Emily Jarvie2021-11-04 18:27:302021-11-04 18:27:30FDA Approves First Clinical Trial Using Naturally Sourced Psychedelics
This trial, using Filament Health's botanical drug candidates, is the first to assess the direct administration of psilocin.
https://psychedelicspotlight.com/wp-content/uploads/2021/10/Psychedelic_Spotlight_Business_Roundup_October_29_Cybin_Mindcure_MindMed_Silo_Awakn_Mydecine.jpg 962 1920 Emily Jarvie https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Emily Jarvie2021-10-29 16:39:312022-06-07 23:23:46Psychedelic Business Spotlight: October 29
This week in psychedelic business news: MindMed's MDMA research pipeline to treat Autism Spectrum Disorder; Cybin EMBARKs; Awakn and MindCure partner to heal alcoholism.
https://psychedelicspotlight.com/wp-content/uploads/2021/10/FDA_Backs_Cybin_Kernal_Neuroimaging_Device_Psychedelic_Spotlight.jpg 875 1310 Emily Jarvie https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Emily Jarvie2021-10-26 18:06:342021-10-26 18:06:34FDA Authorizes Cybin Device to Quantify Psychedelics’ Effects on the Brain
"This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding," says Cybin's chief clinical officer.
https://psychedelicspotlight.com/wp-content/uploads/2021/08/ketamine_treatment_als_psychedelic_spotlight.jpg 850 1310 Emily Jarvie https://psychedelicspotlight.com/wp-content/uploads/2023/01/PS_LOGO_PRIMARY_DOT_WHT-1.png Emily Jarvie2021-08-04 16:16:562021-08-04 16:17:00FDA Green Lights Ketamine for Treatment of ALS
"This designation not only expedites our regulatory, clinical, and product development plans but also validates our belief in the potential of ketamine," says PharmaTher CEO Fabio Chianelli.