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Medical Research › Controlled Substances Act › Pharmaceutical Industry

Ropes & Gray LLP

HALT Fentanyl Act: Unpacking its Significant Reforms for Controlled Substance Research

Ropes & Gray LLP on

On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more

Husch Blackwell LLP

All the Outcomes of a Marijuana Reschedule

Husch Blackwell LLP on

Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When...more

Amundsen Davis LLC

Historic Cannabis Rescheduling on the Horizon? It's Up to the DEA Now

Amundsen Davis LLC on

In October of 2022, the Biden Administration started an official cannabis policy review process, which began with granting pardons to all people convicted of simple cannabis possession under federal law. At the time, this was...more

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

Vicente LLP on

On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...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Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs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On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more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FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs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

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The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.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

Knobbe Martens

Research into Cannabidiol (CBD) Progresses

Knobbe Martens on

Kalytera Therapeutics, clinical-stage pharmaceutical company, recently announced plans for clinical trials focused on the treatment of Graft versus Host Disease using Cannabidiol (CBD), a compound found in cannabis. This...more

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