FDA Releases Draft Guidance for Psychedelic Drugs Research

June 29, 2023 · Ganjapreneur

The U.S. Food and Drug Administration (FDA) on Monday released its Draft Guidance for research of psychedelic drugs. The guidance covers psilocybin, LSD, and substances such as MDMA.

The guidance mirrors the good practices required by other drug and therapeutic companies, including compliance with the federal Food, Drug, and Cosmetics Act and that non-clinical investigations should follow 2010’s Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. The guidance also details which psychedelic drugs would be considered botanical and nonbotanical.

The FDA notes that most of the medical conditions being studied to date in psychedelic research programs are chronic. The proposed regulations lay out the processes for psychedelic therapy, which is legal in Oregon.

The agency says that were it to approve a drug that currently falls under Schedule I status of the Controlled Substances Act, “the abuse potential assessment would assist in determining an appropriate rescheduling action” under the CSA.

The FDA is accepting public comments on the proposed rules until August 28. (Full Story)

Next Post

Is Aaron Rodgers the Face of Psychedelics in America?

This week, a psychedelics conference in Denver attracted a diverse gathering of thousands, including podcasters, vendors, startups, and seekers. Javier Hasse of Benzinga was one of the attendees who immersed themselves in a captivating atmosphere, exploring a dimly lit hall adorned with…
Read
Previous Post

New Jersey Senators Discuss Top Lawmaker’s Psilocybin Legalization Bill In Committee

A New Jersey Senate committee held a hearing on Monday to discuss a bill that would legalize the possession, home cultivation and gifting of psilocybin mushrooms for adults 21 and older while also creating a system of licensed businesses to…
Read
Random Post

New President of Ecuador Makes Drug Possession Illegal Again

Ecuador’s newly-elected president has re-outlawed drug possession just a few days after taking power as part of a campaign promise to crack down on narcotics trafficking. President Daniel Noboa announced Thursday, less than two days after taking office, that he…
Read
Random Post

Schumer Says Marijuana Banking Is Among Senate’s 2024 Priorities, But Acknowledges It ‘Won’t Be Easy’

Senate Majority Leader Chuck Schumer (D-NY) says lawmakers will “hit the ground running” in 2024, aiming to build on bipartisan progress on several key issues, including marijuana banking reform—though he noted it “won’t be easy.” As the Senate recesses for…
Read
Random Post

Delaware Senators Send House-Passed Marijuana Sales Bill To The Floor, Alongside Legalization Measure

A second Delaware Senate committee approved a House-passed bill on Thursday to create a regulated adult-use marijuana market, sending it to the floor where a complementary measure to legalize possession is also set for action. The proposals are being sponsored…
Read
Random Post

Does Health Insurance Cover Mushrooms and
Psychedelics? (Even with a Doctor's Note?)

It may seem far-fetched to have a health insurance company pay for an ecstasy or magic mushroom trip, but the psychedelics market is already crunching the statistics and proposing US insurers. Early results from clinical trials on substances like MDMA and psilocybin…
Read