From Our Perspective
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.
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