May 25, 2022

Open Data: U.S. Food and Drug Administration Launches openFDA

From an Introductory Blog Post

Through openFDA, developers and researchers will have easy access to high-value FDA public data through RESTful APIs and structured file downloads. In short, our goal is to make it simple for an application, mobile, or web developer, or all stripes of researchers, to use data from FDA in their work.

From the openFDA Web Site:

On launch, openFDA will provide API and raw download access to a number of high-value structured datasets. Additionally, openFDA will provide a platform for public challenges issued by the FDA and a place for the community to interact with each other and FDA domain experts with the goal of spurring innovation around FDA data.

We’re currently focused on working on datasets in the following areas:

  • Adverse Events: FDA’s Adverse Event Reporting System, a database that contains millions of adverse event and medication error reports submitted to FDA covering all regulated drugs.
  • Recalls: Enforcement Report and Product Recalls Data, containing information gathered from public notices about certain recalls of FDA-regulated products.
  • Documentation: Structured Product Labeling Data, containing detailed product label information on many FDA-regulated products

Beta access to the datasets via APIs or download capabilities is anticipated for this Summer, with a larger public release in Fall.

Links and Resources

About Gary Price

Gary Price ( is a librarian, writer, consultant, and frequent conference speaker based in the Washington D.C. metro area. Before launching INFOdocket, Price and Shirl Kennedy were the founders and senior editors at ResourceShelf and DocuTicker for 10 years. From 2006-2009 he was Director of Online Information Services at, and is currently a contributing editor at Search Engine Land.