DDOD use case to request access historical label revisions of FDA-approved drugs.
WHAT IS A USE CASE?
A “Use Case” is a request that was made by the user community because there were no available datasets that met their particular needs. If this use case is similar to your needs, we ask that you add your own requirements to the specifications section.
The concept of a use case falls within the Demand-Driven Open Data (DDOD) program and gives you a formalized way to identify what data you need. It’s for anyone in industry, research, media, nonprofits or other government agencies. Each request becomes a DDOD use case, so that it can be prioritized and worked on.
Use Cases also provide a wealth of insights about existing alternative datasets and tips for interpreting and manipulating data for specific purposes.
Drug manufacturers and distributions submit documentation about their products to FDA in Structured Product Labeling (SPL) that is available via openFDA. However, the approved labeling is a "living document" that is updated over time to reflect increased knowledge about the safety and effectiveness of the drug. The real-time nature of the labeling information makes it difficult to track the historical changes to a product's label and indications.
The historical context of a product's label and indications is important in understanding how and why product labeling changes and in evaluating pharmaceutical market access.
USE CASE SPECIFICATIONS & SOLUTION
Information about this use cases is maintained in a wiki: http://hhs.ddod.us/wiki/Use_Case_25:_History_for_structured_product_labels
It serves as a knowledge base.
USE CASE DISCUSSION FORUM
All communications between Data Users, DDOD Administrators and Data Owners are logged as discussions within GitHub issues: https://github.com/demand-driven-open-data/ddod-intake/issues/25
It aims to provide complete transparency into the process and ensure the same message gets to all participants.
Closed via DailyMed, which has XML files of historical SPLs
Data and Resources
- openFDA prescription and over-the-counter (OTC) drug labelingjson
Every prescription drug (including biological drug products) approved by FDA...
- National Library of Medicine (NLM) DailyMed SPL filesxml
XML files of SPL data, which allows for searching of historical labels....
- National Library of Medicine RxNorm APIRESTful
RxNorm is: (1) normalized naming system for generic and branded drugs; and (...
|Release Date|| |
|Temporal Coverage|| |
|Contact Name|| |
|Public Access Level|| |
|Bureau Code|| |
009:00 - Department of Health and Human Services
|Program Code|| |
009:002 - Department of Health and Human Services - Human Drugs