FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development

By: Cassandra L. Taylor, public health advisor, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Schuyler Pruyn, project manager, Office of Executive Programs, CDER

FDA has a long history of reviewing clinical research for cannabis (such as marijuana and hemp) and cannabis-derived products (such as cannabidiol or CBD). Since the early 1970s, FDA has received more than 800 investigational new drug applications (INDs) for, and pre-investigational new drug applications (pre-INDs) related to cannabis and cannabis-derived products (CCDP). Over the last 10 years, there has been increased interest in studying CCDPs as medical treatment options. We have received double the number of IND and pre-IND applications during this time. We also have seen increased clinical research of new types of cannabis products and routes of administration (ROA), which is the way the drug is administered in the body.

More with Cassandra L. Taylor and Schuyler Pruyn

 

Previous From Our Perspectives

2023

• FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development
• Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
• CDER Takes Measures to Tackle Stimulant Use Disorder
• CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
• CDER’s Efforts to Expand Opioid Disposal Options
• FDA actions to continue to ensure the safety of the nation’s drug supply
• CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program
• From Our Perspective: CDER’s Continued Efforts to Widen Naloxone Access
• From Our Perspective: Risk Evaluation and Mitigation Strategies (REMS), Part 2 - Implementation: Challenges and Opportunities
• A Two-Part Series: Risk Evaluation and Mitigation Strategies (REMS) Program

2022

• FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time
• FDA Issues Draft Guidances on Real-World Evidence, Prepares to Publish More in Future

2021

• 50 Years of Progress in Treating Patients with Cancer
• FDA Holds Workshop to Discuss the Safe Use of Benzodiazepines
• FDA Approval Demonstrates the Role of Real-World Evidence in Regulatory Decision-Making on Drug Effectiveness
• CURE ID Moves to Automated Data Collection in Light of COVID Pandemic
• FDA’s Decision to Approve New Treatment for Alzheimer’s Disease
• Generic Drugs in the 21st Century: FDA’s Actions Create Transparency and Value for Complex Generic Product Development
• FDA and Duke-Margolis Host Workshop on Scientific and Ethical Considerations for Including Pregnant People in Clinical Trials

2020

• The Orange Book at 40: A valued FDA resource continually enhanced by user input
• Bad Ad Program at 10, Educating Healthcare Providers to Recognize and Report Potentially False or Misleading Prescription Drug Promotion