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

Description

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

General Information

• This data is described at

  http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know

• This data is published by

  U.S. Department of Health & Human Services Do you think this data is incorrect? Let us know

Legal Information

• The rights statement is at

  http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know

• Outside the US, this data is available under

  Creative Commons CCZero Do you think this data is incorrect? Let us know

• There are

  yes, and the rights are all held by the same person or organisation Do you think this data is incorrect? Let us know

• The content is available under

  Creative Commons CCZero Do you think this data is incorrect? Let us know

• The rights statement includes data about

  its data licence Do you think this data is incorrect? Let us know

• This data contains

  no data about individuals Do you think this data is incorrect? Let us know

Practical Information

• The data appears in this collection

  http://catalog.data.gov/organization/hhs-gov Do you think this data is incorrect? Let us know

• The accuracy or relevance of this data will

  go out of date but it is timestamped Do you think this data is incorrect? Let us know

• The data is

  backed up offsite Do you think this data is incorrect? Let us know

Technical Information

• This data is

  machine-readable Do you think this data is incorrect? Let us know

• The format of this data is

  a standard open format Do you think this data is incorrect? Let us know

Social Information

• The documentation includes machine-readable data for

  title Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  description Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  identifier Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  landing page Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  publisher Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  keyword(s) or tag(s) Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  distribution(s) Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  release date Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  modification date Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  temporal coverage Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  language Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  release date Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  a URL to access the data Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  a URL to download the dataset Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  type of download media Do you think this data is incorrect? Let us know

• Find out how to contact someone about this data at

  http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know

• Find out how to suggest improvements to publication at

  http://www.data.gov/issue/?media_url=http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know