Title |
FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science
|
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Published in |
Drug Discovery Today, June 2016
|
DOI | 10.1016/j.drudis.2016.06.006 |
Pubmed ID | |
Authors |
Hong Fang, Stephen C. Harris, Zhichao Liu, Guangxu Zhou, Guoping Zhang, Joshua Xu, Lilliam Rosario, Paul C. Howard, Weida Tong |
Abstract |
Here, we provide a concise overview of US Food and Drug Administration (FDA) drug labeling, which details drug products, drug-drug interactions, adverse drug reactions (ADRs), and more. Labeling data have been collected over several decades by the FDA and are an important resource for regulatory research and decision making. However, navigating through these data is challenging. To aid such navigation, the FDALabel database was developed, which contains a set of approximately 80000 labeling data. The full-text searching capability of FDALabel and querying based on any combination of specific sections, document types, market categories, market date, and other labeling information makes it a powerful and attractive tool for a variety of applications. Here, we illustrate the utility of FDALabel using case scenarios in pharmacogenomics biomarkers and ADR studies. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Germany | 1 | 100% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 66 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 14 | 21% |
Student > Master | 13 | 20% |
Student > Bachelor | 5 | 8% |
Student > Ph. D. Student | 4 | 6% |
Student > Postgraduate | 4 | 6% |
Other | 6 | 9% |
Unknown | 20 | 30% |
Readers by discipline | Count | As % |
---|---|---|
Pharmacology, Toxicology and Pharmaceutical Science | 14 | 21% |
Chemistry | 7 | 11% |
Biochemistry, Genetics and Molecular Biology | 6 | 9% |
Agricultural and Biological Sciences | 4 | 6% |
Nursing and Health Professions | 3 | 5% |
Other | 12 | 18% |
Unknown | 20 | 30% |