News & Analysis as of

Controlled Substances Act Clinical Trials Food and Drug Administration (FDA)

McGuireWoods LLP

Interest in Psilocybin Continues to “Mushroom” for Potential Mental Health Treatment

McGuireWoods LLP on

Interest in the potential for psilocybin to be developed as a mental health treatment has continued to grow in recent months, due in part to recent activity by the U.S. Food and Drug Administration (FDA) and Drug Enforcement...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Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs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On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more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FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs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

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

Latham & Watkins LLP

FDA Finalizes Quality Recommendations for Cannabis in Clinical Investigations

Latham & Watkins LLP on

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

Perkins Coie on

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

BakerHostetler on

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

MoFo Life Sciences on

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

Womble Bond Dickinson

Psilocybin May Brighten the Future for Depression Patients

Womble Bond Dickinson on

The Struggle is Real - Over 17 million people in the United States are diagnosed with major depressive disorder (MDD). Antidepressants and psychotherapy are the leading forms of treatment; however, antidepressants are not...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

Womble Bond Dickinson

FDA Issues Guidance on Clinical Research for Cannabis Drugs

Womble Bond Dickinson on

On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) released a new draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The draft guidance is intended to...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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