FDALabel Tool
| Developer(s) | U.S. Food and Drug Administration |
|---|---|
| Stable release | 2.5.1
/ August 14, 2020 |
| Engine | |
| Type | Application for public use |
| Website | www.fda.gov/FDALabelTool [1] |
Search FDALabel Tool on Amazon.
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.[citation needed]
References
- ↑ 1.0 1.1 "FDALabel". FDALabel: Full-Text Search of Drug Product Labeling. Retrieved 10 December 2021.
- ↑ "Structured Product Labeling (SPL)". Structured Product Labeling Resources. U.S. Food and Drug Administration. Retrieved 4 September 2021.
- ↑ "FDA Online Label Repository". FDA Online Label Repository. U.S. Food and Drug Administration. Retrieved 4 September 2021.
- ↑ Wu, Leihong; Ingle, Taylor; Liu, Zhichao; Zhao-Wong, Anna; Harris, Stephen; Thakkar, Shraddha; Zhou, Guangxu; Yang, Junshuang; Xu, Joshua; Mehta, Darshan; Ge, Weigong; Tong, Weida; Fang, Hong (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. PMC 6419320. PMID 30871458. 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): 103896. doi:10.1016/j.jff.2020.103896. Retrieved 10 December 2021. Unknown parameter
|s2cid=ignored (help) - ↑ 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 Reflected by US Product Labeling: Statistical Review". Therapeutic Innovation & Regulatory Science. 54 (Nov 2020): 1436–1443. doi:10.1007/s43441-020-00170-y. PMID 32514737 Check
|pmid=value (help). Unknown parameter|s2cid=ignored (help) - ↑ Fang, Hong; Harris, Stephen; Liu, Zhichao; Thakkar, Shraddha; Yang, Junshuang; Ingle, Taylor; Xu, Joshua; Lesko, Lawrence; Rosario, Lilliam; Tong, Weida (Nov 24, 2020). "FDALabel for Drug Repurposing Studies and Beyond". Nature Biotechnology. 38 (December 2020): 1378–1379. doi:10.1038/s41587-020-00751-0. PMID 33235392 Check
|pmid=value (help). Retrieved 10 December 2021. Unknown parameter|s2cid=ignored (help) - ↑ M. Rudrapal; S. Khairnar; A. Jadhav (2020). "1". In Badria, Farid. Drug Repurposing: Hypothesis, Molecular Aspects and Therapeutic Applications. London, United Kingdom: IntechOpen. pp. 3–22. ISBN 978-1-83968-520-0. Retrieved 10 December 2021. Search this book on
- ↑ Mehta, Darshan; Uber, Ryley; Ingle, Taylor; Li, Catherine; Liu, Zhichao; Thakkar, Shraddha; Ning, Baitang; Wu, Leihong; Yang, Junshuang; Harris, Steven; Zhaou, Guangxu; Xu, Joshua; Tong, Weida; Lesko, Lawrence; Fang, Hong (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 Check
|pmid=value (help). Retrieved 10 December 2021. Unknown parameter|s2cid=ignored (help) - ↑ 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. PMC 6434454. PMID 30253665.
- ↑ 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): 225. doi:10.1208/s12249-020-01744-7. PMC 7405756 Check
|pmc=value (help). PMID 32761294 Check|pmid=value (help). 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. Retrieved 10 December 2021. Unknown parameter
|s2cid=ignored (help) - ↑ 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. PMC 8263276 Check
|pmc=value (help). PMID 34234357 Check|pmid=value (help). Retrieved 10 December 2021.
This article "FDALabel Tool" is from Wikipedia. The list of its authors can be seen in its historical and/or the page Edithistory:FDALabel Tool. Articles copied from Draft Namespace on Wikipedia could be seen on the Draft Namespace of Wikipedia and not main one.
