FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science.
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 this 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.
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Hong
H
Fang
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Stephen C
SC
Harris
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Zhichao
Z
Liu
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Guangxu
G
Zhou
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Guoping
G
Zhang
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Joshua
J
Xu
Office of Computational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20903, USA.
Lilliam
L
Rosario
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Paul C
PC
Howard
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA. Electronic address: weida.tong@fda.hhs.gov.
Weida
W
Tong
D016208:Databases, Factual; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D020407:Internet; D057285:Precision Medicine; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*