Details
The U.S. Food and Drug Administration (FDA) has tasked the Sentinel Operations Center (SOC) with conducting reviews of the medical literature related to cannabis use in order to inform some of the work of FDA’s Center for Drug Evaluation and Research (CDER). The specific aims of these literature reviews are to:
- Evaluate and interpret the literature of observational and (except where noted) interventional studies of delta-9-tetrahydrocannabinol (THC)-containing cannabis or cannabis formulations to:
- Evaluate the evidence on harms from nonmedical use, relative to nonmedical use of comparator drugs and relative to non-use, by examining observational studies only.
- Evaluate the evidence on harms from cannabis medical use. Harms associated with the use of medical cannabis include, but are not limited to, psychiatric or behavioral reactions, central nervous system depression, neurological conditions, cardiac conditions, gastrointestinal conditions, and cannabis use disorder.
- Evaluate the harms from cannabis use, where the intent of use is uncertain, by examining observational studies only.
- Critically evaluate observational and interventional studies that assess the effectiveness of cannabis for various therapeutic uses.
Contributors
Amie Goodin, PhD; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL
Lauren Adkins, MLIS; Shao-Hsuan Chang; Hung-Kai Chen; Hannah Fechtel; Dawei Guan; Serena Guo, PhD; Wenxi Huang; Sebastian Jugl; Pareeta Kotecha; Hsin-Yueh Lin; Shu Niu; Yan Wang, PhD; Almut Winterstein, PhD, FISPE; Tianxiao Zhang; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL
Dominic Chiapperino, PhD; Steven Galati, MD; Joshua Lloyd, MD; Controlled Substance Staff, Office of the Center Director, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Catherine Callahan, PhD, MA; Christina Greene, PhD; Sara Karami, PhD, MPH; Kira Leishear, PhD, MS; Tamra Meyer, PhD, MPH; Dave Moeny, RPh, MPH; Silvia Perez-Vilar, PhD, PharmD; Rose Radin, PhD, MPH; Suhkminder Sandhu, PhD, MS, MPH; Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Patricia Bright, PhD, MSPH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Judith C. Maro, PhD, MS; Ryan Schoeplein, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA