By Delia Ann Deschaine and Megan Robertson U.S. cannabis businesses operate in an increasingly complex legal and regulatory environment. Many, if not most, of those complexities stem from marijuana’s classification in Schedule I of the federal Controlled Substances Act. That classification hinges on the determination that marijuana lacks a currently accepted medical use in treatment […]
clinical research
FDA’s Draft Guidance for Clinical Research Regarding Cannabis and Cannabis Derivatives Takes a Firm Stance on the 0.3% THC Level
By Agustin Rodriguez and Dascher Pasco On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” This is the first draft guidance from the FDA regarding the cannabis industry, and while nothing stated was surprising to those within the […]