openFDA was implemented in support of the 2013 Executive Order "Making Open and Machine Readable the New Default for Government Information" which was superseded by the 2019 "Open, Public, Electronic, and Necessary, (OPEN) Government Data Act"

The concept was to index high-value, high priority and scalable public-access data, format and document that data in developer and consumer-friendly standards, and make that data available via a public-access portal that enables developers to quickly and easily use it in applications. Dr. Kass-Hout launched the project by obtaining a Presidential Innovation Fellow to focus on policy and programmatic issues in July 2013. The public cloud environment was determined in September 2013, and Dr. Kass-Hout's team solicited agency and user input into policies, first priority datasets, and desirable technical characteristics of openFDA. All the project milestones were met despite the government shutdown.

openFDA launched on June 2, 2014, at https://open.fda.gov. It features an open user community for sharing open source code, examples, and ideas. By September 2014, medical device reports, enforcement reports, and drug adverse event reports were available, and every mention of a drug in those reports was automatically augmented with full data from various drug datasets, including codes and label information.

Since its launch, several new datasets have been added to openFDA. For more information about the new datasets, please review the openFDA Updates webpage accessible via this hyperlink: https://open.fda.gov/about/updates/. Also, since its launch, openFDA has been visited by tens of thousands of entities from around the globe and is used by several websites.

openFDA provides APIs and raw download access to a number of high-value, high priority and scalable structured datasets, including adverse events, drug product labeling, and recall enforcement reports.

In May 2015, FDA announced the first openFDA challenge to the developer community. For more details regarding that challenge, please see this webpage: An Open Challenge to Tap Public Data.

The best place to start is on the API basics page. It provides a great introduction to openFDA and how you can begin developing using the platform. We're also active on GitHub, Twitter, and StackExchange. If there is a unique partnership opportunity or other collaboration you wish to discuss, you can email us at open@fda.hhs.gov.

openFDA is an initiative in the Office of Health Informatics (OHI) at the Food and Drug Administration.