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DEA Clinical Trials

Husch Blackwell LLP

Psychedelic Breakthroughs: Key Considerations for Clinical Trials

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Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet...more

Husch Blackwell LLP

The First Leap to Receive Approval for a Novel Approach to PTSD Treatment

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On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of...more

Alston & Bird

Health Care Week In Review: HHS Awards $218 Million in Grant Funding

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Amundsen Davis LLC

FDA Issues First Ever Guidance for Research of Psychedelics

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Earlier this summer, the Food & Drug Administration (FDA) issued draft guidance for those researching the use of psychedelics to treat certain serious medical conditions including major depressive disorder, PTSD, and...more

Foley & Lardner LLP

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

Foley & Lardner LLP on

On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more

Gardner Law

FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs

Gardner Law on

Lastly, there are several clinical factors the Agency encourages sponsors to consider. One way psychedelics differ from other drugs is that the use of a traditional placebo as a control may be challenging, as an active drug...more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

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Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

Latham & Watkins LLP

FDA Finalizes Quality Recommendations for Cannabis in Clinical Investigations

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FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act. Key Points: ..The Food and Drug...more

Perkins Coie

FDA Releases Guidance on Clinical Research into Cannabis-Derived Drugs

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The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or...more

BakerHostetler

FDA Issues Guidance on Clinical Research with Cannabis

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On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more

MoFo Life Sciences

Senators Call For Report On State Of Psychedelic Research

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Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) urging both agencies to advance research on the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - April 2022: Watching the Pot™

APA Challenges to DEA Cannabis Policy: "Hot" Hemp and Research-Grade Cannabis - The beginning of spring brought some interesting developments in administrative legal challenges to the U.S. Drug Enforcement Administration...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - April 2022

Thank you for reading the April 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss two ongoing administrative legal challenges to the U.S. Drug Enforcement Administration's policies on...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - October 2021: Watching the Pot™

DEA Calls for Increased Production Quotas for Research-Grade Cannabis and Psychedelics in 2022 - While it may come as a surprise to some, the U.S. Drug Enforcement Administration (DEA) has called for significantly...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - October 2021

The October 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses a precedential TTAB decision regarding fraud; the DEA's proposal to increase production quotas for several schedule I controlled substances,...more

Womble Bond Dickinson

DEA Set to Allow More Facilities to Produce Marijuana for Research: A Victory for Cannabis Growers, Researchers and the DEA?

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Although many states have legalized marijuana for medicinal and/or recreational use, when it comes to using marijuana in a research setting, sources have been very limited.  The US Drug Enforcement Administration (DEA) has...more

BakerHostetler

FDA Provides Playbook for Developing Cannabis Drugs

BakerHostetler on

The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the...more

Epstein Becker & Green

FDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review

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FDA took two important steps last week to clarify the regulatory landscape for cannabis products, including CBD products. First, FDA issued a draft guidance on Quality Considerations for Clinical Research Involving Cannabis...more

Snell & Wilmer

From Seed to Study Subject: New Draft Guidance From the FDA and Four Takeaways for Using Cannabis in Clinical Trials

Snell & Wilmer on

Earlier this week, the U.S. Food and Drug Administration (FDA) released draft guidance on the use of cannabis and cannabis-derived compounds in clinical research. This guidance represents an important step towards normalizing...more

Benesch

The Proponent Testimony Goes Unrefuted As Renowned Physician Dr. Sue Sisley Highlights The Testimony Of Ten Witnesses Before The...

Benesch on

Thursday, February 17, 2016, was the first evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”), which heard a full complement of testimony, all in support of legalizing medical...more

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