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5.4 Open FDA

This new flagship initiative provides an exciting opportunity to spur innovation, advance regulatory science, and empower decision-making by providing software developers, researchers, consumers and health professionals, easy access to valuable FDA public data, making it simpler for them to use this data in their work to advance and promote the public health. The initiative leverages new technologies and methods such as cloud computing and open source software to unlock the tremendous public data and resources at FDA in a user-friendly way. OpenFDA will provide application developers (such as mobile app creators, web developers, and data visualization makers) the ability to quickly access datasets from FDA in structured, machine-readable formats so that they can be understood and parsed by a computer. By having the data available in this way, developers and innovators can create applications that quickly search, query or pull massive amounts of information instantaneously and directly from FDA on an “as needed basis”, rather than having to download huge amounts of data and then reconstructing a usable database.

OpenFDA utilizes a search-based API to collect large amounts of existing public data such as Adverse Event Reports, Product Recalls, and Labeling that is of interest to consumers, the industry, and the public health community.  This offers developers the ability to search through text within that data, ranking results much like a search using common web-based search engines would do. This method then allows them to build their own applications on top of OpenFDA, giving them a large amount of flexibility to determine what types of data they would like to search and how they would like to present that data to end-users. This enables a wide variety of applications to be built on one common platform, each with a specific purpose such as identifying critical safety signals, comparing related data, or informing trend analyses. This novel approach to data organization offers a scalable platform that can be easily searched and queried across many distinct datasets.  It allows the locating  of common identifiers when possible in a lightweight, reusable fashion that can be easily redeployed or altered to fit a variety of purposes, and provides an innovative “big data search and analytics solution”.  OpenFDA is launching a phased approach for this initiative so all datasets may not be available at the time of publication; however, the power of this new informatics tool will continue to offer tremendous benefits as additional phases are completed and new datasets are made available.

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