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Expanding Patient Access to Investigational New Drugs
| Content Provider | Semantic Scholar |
|---|---|
| Author | Norman, Gail A. Van |
| Copyright Year | 2018 |
| Abstract | Summary 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. |
| Starting Page | 403 |
| Ending Page | 414 |
| Page Count | 12 |
| File Format | PDF HTM / HTML |
| DOI | 10.1016/j.jacbts.2018.02.001 |
| PubMed reference number | 30062226 |
| Journal | Medline |
| Volume Number | 3 |
| Alternate Webpage(s) | https://api.elsevier.com/content/article/pii/S2452302X18300603 |
| Alternate Webpage(s) | https://www.sciencedirect.com/science/article/pii/S2452302X18300603 |
| Alternate Webpage(s) | https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c0/e9/main.PMC6058931.pdf |
| Alternate Webpage(s) | https://doi.org/10.1016/j.jacbts.2018.02.001 |
| Journal | JACC: Basic to Translational Science |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
