Prescribing information for approved human prescription drug and biological products contains a summary of the essential scientific information needed for the safe and effective use of the product. Animal prescription and animal OTC product labeling.Unapproved homeopathic prescription and homeopathic OTC products.Products marketed under the monograph system.Other biological products (e.g., blood products, allergenics, cellular therapy).Therapeutic biologics and monoclonal antibodies.Human prescription drug and biological product labeling including prescribing information, patient labeling, and carton and container labeling:.The FDALabel Database includes the following types of labeling: Another publication demonstrated how a systematic classification scheme using FDA-approved drug labeling was developed to assess a drug’s potential for drug-induced liver injury, thus illustrating the utility of FDALabel Database 8.īack to Top What drug labeling is included in the database? For example, recent publications describe how information in drug labeling can be used to aid and facilitate drug repurposing 4 as well as applications in precision medicine, drug safety, and regulatory science 5-7. You can use the wealth of information in the FDALabel Database in many cases including as a healthcare provider for quick access to drug indications and warnings, as a pharmaceutical company for drug development, or as a researcher studying drug safety. ** Includes drug products, therapeutic biologics, vaccines, plasma derivatives, allergenics (standardized and non-standardized), cellular therapy, and licensed minimally manipulated cells. * Includes Human OTC drugs approved for marketing through a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or the OTC monograph system. Human Prescription Drugs and Biological Products**Īnimal Prescription and Animal OTC Products The following table lists the count of several common labeling types in FDALabel.
Drug reference tool archive#
The source of FDALabel's data is the FDA's Structured Product Labeling (SPL) 1 archive 2, 3, which stores labeling documents submitted by manufacturers. FDALabel is implemented as a secure three-tier application with an Oracle database. The FDALabel Database is a web-based application used to perform customizable searches of over 140,000 human prescription, biological, over-the-counter (OTC), and animal drug labeling documents.
DynaMed is updated multiples times a day.FDALabel Version 2.5 Provide feedback or request assistance by contacting: NCTR Bioinformatics Overview of FDALabel Database Each module is evaluated for clinical relevance and scientific validity. Contains topic summaries created by physicians, for physicians. Medical information with access to textbooks, practice guidelines, patient education and multimedia resources.Ī clinical reference tool created for use at the point of care. Contact the library if you have further questions. This is a known issue that BMJ is working to resolve. Important: BMJ Best Practice asks users to accept cookies when moving between pages on the site despite users agreeing to accept cookies. Comprehensive medical information with access to a core collection of textbooks, practice guidelines, patient education and multimedia resources.įast and easy access to continuously updated information for evaluation, diagnosis and treatment of a variety of diseases, including a comorbidities tool.
0 kommentar(er)
