Software:FDALabel Tool
| Developer(s) | U.S. Food and Drug Administration |
|---|---|
| Stable release | 2.5.1
/ August 14, 2020 |
| Type | Application for public use |
| Website | www.fda.gov/FDALabelTool [1] |
FDALabel is a publicly available web-based application used to search a database containing current FDA prescription and over-the-counter (OTC) drug labeling documents.[1] This web-based tool was developed and is maintained by the National Center for Toxicological Research (NCTR) of the U.S. Food and Drug Administration (FDA). FDALabel’s data source is the FDA's Structured Product Labeling (SPL), composed of labeling documents submitted by drug manufacturers, and includes patient and prescribing information, carton and container labeling, labeling for biologics and vaccines, and more.[2][3]
Features
FDALabel allows users to search for text appearing anywhere within drug labeling documents, text within specific labeling sections (e.g., “diabetes” within INDICATIONS AND USAGE), or specific features (e.g., BOXED WARNING). The user-friendly interface also supports searches by drug name or by pharmacologic class, such as Serotonin Reuptake Inhibitors or beta-Adrenergic Blockers. Search results can be exported in spreadsheet format and saved for further analysis. A unique weblink (URL address) is generated with each search that allows users to share and repeat searches.[1]
Application
FDALabel's up-to-date database provides a reliable labeling resource and can be used to evaluate serious adverse drug reactions, regulatory review, and impacts of labeling.[4][5][6] The tool allows easy access to information and has been used to support drug development, drug repurposing, and personalized medicine.[7][8][9][10] FDALabel has been used to collect information in studies of COVID-19 vaccines, post marketing risks of monoclonal antibodies (mAbs), and assessments of orphan drugs.[11][12][13]
Accessibility
FDALabel is freely available for public use.
References
- ↑ 1.0 1.1 "FDALabel". https://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling.
- ↑ "Structured Product Labeling (SPL)". U.S. Food and Drug Administration. https://www.fda.gov/industry/fda-resources-data-standards/structured-product-labeling-resources.
- ↑ "FDA Online Label Repository". U.S. Food and Drug Administration. https://labels.fda.gov.
- ↑ Wu, Leihong; Ingle, Taylor; Liu, Zhichao; Zhao-Wong, Anna; Harris, Stephen; Thakkar, Shraddha; Zhou, Guangxu; Yang, Junshuang et al. (March 2019). "Study of Serious Adverse Drug Reactions Using FDA-approved Drug Labeling and MedDRA". BMC Bioinformatics 20 (2): 97. doi:10.1186/s12859-019-2628-5. https://rdcu.be/cCWLO. Retrieved 10 December 2021.
- ↑ Díaz, Laura Domínguez; Fernández-Ruiz, Virginia; Cámara, Montaña (May 2020). "An international regulatory review of food health-related claims in functional food products labeling". Journal of Functional Foods 68 (103896). doi:10.1016/j.jff.2020.103896. https://www.sciencedirect.com/science/article/pii/S1756464620301201. Retrieved 10 December 2021.
- ↑ Seifu, Yodit; Gamalo‑Siebers, Margaret; Barthel, Friederike; Lin, Junjing; Qiu, Junshan; Cooner, Freda; Ruan, Shiling; Walley, Rosalind (June 2020). "Real‑World Evidence Utilization in Clinical Development Refected by US Product Labeling: Statistical Review". Therapeutic Innovation & Regulatory Science 54 (Nov 2020): 1436-1443. doi:10.1007/s43441-020-00170-y. https://rdcu.be/cCZ9G.
- ↑ Fang, Hong; Harris, Stephen; Liu, Zhichao; Thakkar, Shraddha; Yang, Junshuang; Ingle, Taylor; Xu, Joshua; Lesko, Lawrence et al. (Nov 24, 2020). "FDALabel for Drug Repurposing Studies and Beyond". Nature Biotechnology 38 (December 2020): 1378-1379. doi:10.1038/s41587-020-00751-0. https://www.nature.com/articles/s41587-020-00751-0. Retrieved 10 December 2021.
- ↑ M. Rudrapal; S. Khairnar; A. Jadhav (2020). "1". in Badria, Farid (in English). Drug Repurposing: Hypothesis, Molecular Aspects and Therapeutic Applications. London, United Kingdom: IntechOpen. pp. 3-22. ISBN 978-1-83968-520-0. https://books.google.com/books?id=_JQtEAAAQBAJ&source=gbs_navlinks_s. Retrieved 10 December 2021.
- ↑ Mehta, Darshan; Uber, Ryley; Ingle, Taylor; Li, Catherine; Liu, Zhichao; Thakkar, Shraddha; Ning, Baitang; Wu, Leihong et al. (May 2020). "Study of Pharmacogenomic Information in FDA-approved Drug Labeling to Facilitate Application of Precision Medicine". Drug Discov Today 5 (25): 813-820. doi:10.1016/j.drudis.2020.01.023. PMID 32032705. https://pubmed.ncbi.nlm.nih.gov/32032705/. Retrieved 10 December 2021.
- ↑ Walker, Abigail; Imam, Syed; Roberts, Ruth (September 2018). "Drug Discovery and Development: Biomarkers of Neurotoxicity and Neurodegeneration". Experimental Biology and Medicine 243 (13): 1037-1045. doi:10.1177/1535370218801309. https://journals.sagepub.com/doi/full/10.1177/1535370218801309. Retrieved 10 December 2021.
- ↑ Wang, Jieliang; Peng, Ying; Xu, Haiyue; Cui, Zhengrong; Williams, Robert (Aug 2020). "The COVID-19 Vaccine Race: Challenges and Opportunities in Vaccine Formulation". AAPS PharmaSciTech 21 (225). doi:10.1208/s12249-020-01744-7. https://rdcu.be/cCZ9p. Retrieved 10 December 2021.
- ↑ Hagan, John; Ender, Elizabeth; Divekar, Rohit; Pongdee, Thanai; Shah, Nilay; Rank, Matthew (Feb 2021). "Risk of Postmarket Black Box Warnings in FDA Approved Monoclonal Antibodies". The Journal of Allergy and Clinical Immunology 147 (2): AB120. doi:10.1016/j.jaci.2020.12.441. https://www.jacionline.org/article/S0091-6749(20)32204-1/fulltext. Retrieved 10 December 2021.
- ↑ Johann, Pascal; Lenz, Dominic; Ries, Markus (July 2021). "The drug development pipeline for glioblastoma - a cross sectional assessment of the FDA Orphan Drug Product designation database". PLOS ONE 16 (7): e0252924. doi:10.1101/2021.01.01.21249120. https://doi.org/10.1371/journal.pone.0252924. Retrieved 10 December 2021.
See also
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