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#DDOD Use Case: Historical Structured Product Labels for FDA-Approved Drugs

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

Data and Resources

FieldValue
Modified
2016-04-05
Release Date
2015-08-05
Homepage URL
Identifier
e5e30804-72da-4673-920a-b3489d4a8d3f
Temporal Coverage
2009-06-01
License
Granularity
drug label
Author
U.S. Food and Drug Administration
Data Dictionary
Contact Name
Portnoy, David
Contact Email
Public Access Level
Public
Bureau Code
009:00 - Department of Health and Human Services
Program Code
009:002 - Department of Health and Human Services - Human Drugs