@article{10.37349/emed.2023.00179,
abstract = {Since the early 1970s, the U.S. Food and Drug Administration (FDA) has received over 800 investigational new drug applications (INDs) for, and pre-INDs pertaining to, research of cannabis or cannabis-derived products. The current data show that applications for research of these products submitted by both academic researchers and commercial developers focus on four major clinical areas: addiction and pain medicine (53%), neurology (19%), immunology and inflammation (14%), and psychiatry (9%). The product types studied have expanded greatly in recent years and include a wide variety of topical, inhalable, injectable, and oral products. In this article, the authors present a breakdown of cannabis and cannabis-derived applications received by the FDA over the past 50 years. The authors also provide a summary of their experience and challenges in reviewing applications for research of cannabis and cannabis-derived products, as well as recommendations for those interested in studying cannabis and cannabis-derived products in human clinical trials. This perspective article includes a discussion on important IND criteria, the pre-IND consultation program, drug master files (DMFs), and various guidance documents and resources. Lastly, the authors provide their perspective for the future of cannabis drug development.},
author = {Taylor, Cassandra L. and Pruyn, Schuyler A.},
doi = {10.37349/emed.2023.00179},
journal = {Exploration of Medicine},
pages = {813--821},
title = {{A U.S. Food and Drug Administration perspective on cannabis research and drug development}},
url = {https://www.explorationpub.com/Journals/em/Article/1001179},
volume = {4},
year = {2023},
number = {5}
}