SUMMARY

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.

PURPOSE

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.

VALUE

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.

CASE STATUS

Closed via DailyMed, which has XML files of historical SPLs

This dataset represents all technologies available for licensing from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Center for Disease Control and Prevention (CDC).

The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products subject to recall. This database makes it easier for you to determine whether any of the products you have at home are subject to recent recalls, and will be updated as new information becomes available.

Research projects funded by the National Institutes of Health (NIH), other DHHS Operating Divisions (ACF, AHRQ, CDC, FDA, HRSA), and the Department of Veterans Affairs. The ExPORTER files provide weekly and/or yearly snapshots of the data publicly accessible through the NIH Research Portfolio Online Reporting Tools, Expenditures and Results (RePORTER) system at https://reporter.nih.gov. The RePORTER database can also be queried using the user interface or the API. The RePORTER database contains information such as project title, abstract, principal investigator, funded organization, total awarded costs, categorization by area of research (NIH only), and project keywords. Also available is information on research publications and patents that have cited support from each project.