News & Analysis as of

DEA Food and Drug Administration (FDA) Draft Guidance

Gardner Law

FDA's View on Cannabis

Gardner Law on

The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Bradley Arant Boult Cummings LLP

2023: A Good Trip Around the Sun for Psychedelics

2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the...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Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs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On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more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FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs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

Holland & Knight LLP

FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more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The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.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FDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review

Epstein Becker & Green on

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

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