Author + information
- Gail A. Van Norman, MD∗ ()
- ↵∗Address for correspondence:
Dr. Gail A. Van Norman, Department of Anesthesiology and Pain Medicine, University of Washington, 2141 8th Avenue West, Seattle, Washington 98119.
Individual patients with life-threatening or severely debilitating diseases can petition the U.S. Food and Drug Administration (FDA) through their physicians to have expanded access (EA) to drugs that are in clinical trials but have not reached full FDA approval (the “single-patient” investigational new drug [IND] application). Additionally, recent state and federal laws—so-called “right to try legislation”—allow patients to approach drug companies directly for access prior to FDA approval. While these pathways provide potential access for individual patients to investigational drugs, different EA pathways permit entire groups of certain patients to access investigational drugs prior to FDA approval. This review focuses on special categories of EA INDs intended for multiple patients—the intermediate-group IND and the widespread-treatment IND—as well as emergency authorization for use of investigational drugs and biological products (e.g., vaccines) in public health emergencies.
Dr. Van Norman has received financial support from the Journal of the American College of Cardiology.
The author attests he is in compliance with human studies committees and animal welfare regulations of the authors' institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Basic to Translational Science author instructions page.
- Received February 8, 2018.
- Accepted February 23, 2018.
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