The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
If Cannabis Is Reclassified, What Will Happen to the Marketplace? – Diagnosing Health Care
Cannabis Law Now Podcast: What’s Next for Schedule III Marijuana
Podcast - DEA Plants the Seed for Rescheduling Marijuana: What's Next?
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Cannabis Law Now Podcast: THC Infused Beverages: Cantrip's Journey Through the Hemp-Derived Looking Glass
Cannabis Law Now Podcast: The ‘CannaBoies' Lawsuit and Why it Matters
Law of the Land? Cannabis, Preemption, and SCOTUS [More with McGlinchey Ep. 37]
Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
A history of the decline and rise of the marijuana empire
Canna We Talk Cannabis? Emerging Topics in Cannabis Law
2019 Cannabis & Co: Addressing Cannabis in the Workplace (Part 2) - Proposition 64
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Part 1 of 2: The Impact of Marijuana for Employers
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
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
On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more
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
On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs.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
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
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
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
Cannabis legalization advocates are quick to point out a Catch-22 in current legalization debates. On one hand, Cannabis is a Schedule 1 drug under the Controlled Substances Act....more
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
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
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
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
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
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
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
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
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