Vicente LLP provides a full breakdown of the first set of draft rules regarding Colorado’s regulated psychedelics program. The thirty-nine pages of draft rules cover facilitator licensing and training programs, representing months of work by the Natural Medicine Advisory Board and state regulators.
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Vicente LLP shares a high-level overview of the first draft rules for Colorado’s regulated natural medicine market. These draft rules focus on facilitator qualifications, education requirements, and training programs.
We explore the magnitude of opioid settlement funds available in Ohio; the funding mechanisms we expect ibogaine advocates to tap in support of their renewed initiative; why advocates believe Ohio makes sense as a potential champion of this work; and, the challenges ahead for such an ambitious project.
This month: We Explore IP and Exclusivity in 5-MeO-DMT Drug Development Across GH Research and Beckley Psytech • Browse the Interactive Psychedelics Patent Database for Dec 2023 and Jan 2024.
Pα+ Psychedelic Bulletin #156: Canada’s First Published Psilocybin Trial; University of Maryland Joins Terran’s Complaint Against Compass
Canada’s First Published Psilocybin Trial Includes Patients with BDII and Personality Disorders, Employs Flexible Repeat Dosing Protocol • University of Maryland Joins Terran Biosciences’ Complaint Against Compass Pathways • and more…
Pα+: Day 2 Dispatch from ‘Advancing Psychedelic Clinical Study Design’, Hosted by the Reagan-Udall Foundation for the FDA
Our Dispatch from the second day of the Reagan-Udall Foundation for the FDA’s meeting on psychedelic clinical study design focuses on ‘set and setting’, the FDA’s regulatory authority, and ‘real world’ psychedelic use.
Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.
The Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.
It’s exclusively available to our Pα+ subscribers, with new content added regularly.
Pα+ Library: we introduce some of the key concepts in the matter of bifurcated scheduling; a process by which an approved drug product may be placed in a different schedule to the substance itself. As we discuss in this piece, this could have significant repercussions for psychedelic research, legality, and even taxes.
Pα+ Library: we sketch out what a psychedelic REMS might look like, highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.
The Psychedelic News Feed Archives
Archived versions of our Psychedelic News Feed.
This is an archived version of our Psychedelic News Feed, from December 11 2023 – January 7 2024.
This is an archived version of our Psychedelic News Feed, from November 6 – December 10, 2023.
This is an archived version of our Psychedelic News Feed, from October 9 – November 5, 2023.