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September 7 – 13, 2026
This week's feed, sponsored by
Monash University’s Clinical Psychedelic Lab will convene the inaugural Conference for Asia-Pacific Psychedelic Science (CAPS27) in Melbourne, Australia on 24ā26 February 2027. Abstract submissions close in less than one week (18 September 2026). Accepted presenters can apply for a limited number of travel grants.
Apply hereA Note From the Editor
This week, we reported that New Zealandās medicines regulator approved two psychiatrists to offer MDMA to patients with PTSD. (For our story, I spoke with one of the recipients, Dr. Gary Wynn.) That move follows last yearās decision by the same body, Medsafe, to permit two separate clinicians to prescribe psilocybin to patients with treatment-resistant depression.
In doing so, Kiwi regulators are following in the footsteps of their larger neighbour, Australia, which allows certain āauthorised prescribersā to offer the substances for the same conditions. But both programs are modest at present, with cost, and a lack of widespread reimbursement, among the largest barriers.
Still, neither New Zealand nor Australia have actually approved either drug, with the two island nations part of a growing list of countries that have established nontraditional pathways to psychedelic access. Those who are pursuing more conventional market authorisation, meanwhile, are primarily targeting FDA approval in the U.S.
This week, staffers at that agency penned an article in the New England Journal of Medicine outlining what they describe as āFDAās new framework for psychedelic drugsā. It published just days ahead of a four-hour public hearing at the agencyās White Oak campus in Maryland, which will take place tomorrow.
Mondayās meeting is likely to be a dizzying affair, with eighty individuals set to provide comments, either in person or virtually, of no more than two minutes apiece. That leaves around 45 minutes, potentially, for a panel of FDA representatives and those from other federal bodies, like NIDA, SAMHSA, and the VA, to ask questions of speakers.
The commenters hail from various organisations and perspectives, including the worlds of research, advocacy, and industry. Just one late-stage drug developer, Compass Pathways, will speak.
While itās a varied list of presenters, it looks set to be overwhelmingly pro-psychedelic, with just one clearly critical speaker on the agenda: Kevin Sabet of the Foundation for Drug Policy Solutions.
Given the two-minute limit, itās unlikely that anything of real substance or novelty, at least for our readers, will be uttered. I will be placing just as much focus on the questions asked by the FDA and federal partners.
Regardless of substance, the hearing itself is a real milestone for the psychedelics field. Itās also a reminder of just how diverse that field (to the extent that it can even be considered one coherent field) is, with a speaker roster that is set to open with a professor and close with a drug policy reform activist.
So thatās what Monday has in store. On Tuesday, ARPA-H is hosting a Proposersā Day for its ibogaine funding opportunity, ASCENT-IBO. There are various other psychedelics-related meetings throughout the week, too.
Itās a very busy time, then, as psychedelics move from being the subject of clinical trials and regulatory submissions to potential approved medicines, at least in the U.S. To help provide some context as to what might happen after any approval, we put together a ten-minute video that walks you through a timeline of sorts, from approvals to access.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
Davis, Farchione and Colleagues Present FDAās Psychedelic Drug Framework in NEJM
Psychedelic Alpha ā
August 31 – September 6, 2026
A Note From the Editor
Itās been another relatively quiet week in the psychedelics field.
Earlier this week, we published Psychedelic Bulletin 230, which looked at ARPA-Hās ibogaine funding opportunity, among other things.
We also took that break in the news cycle to update our Library entry on Psychedelic REMS, which provides an overview of the subject and a look at what REMS for psychedelic medicines could look like.
We are now gearing up for various hearings and meetings in Washington, DC in the coming weeks, starting with FDAās Public Hearing on Monday 14th of September. Thatās followed by an ARPA-H Proposers Day and more.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
As psychedelics near FDA approval, donors rush to fund the next frontier
Chronicle of Philanthropy ā
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