FDA launches openFDA to provide easy access to FDA public data.
FDA has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public-health datasets collected by the agency. The initiative will make FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as-needed basis.
OpenFDA uses a search-based Application Program Interface (API) to collect large amounts of existing publicly available data, offering developers the ability to search through text within that data. Technology specialists may also 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.
“The openFDA initiative leverages new technologies and methods to unlock the tremendous public data and resources available from the FDA in a user-friendly way,” said Walter S. Harris, the FDA’s chief operating officer and acting chief information officer, in a press release. “OpenFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.”
The initiative is the result of research with internal FDA officials and external developers to identify difficult-to-use datasets in recurrent demand. FDA phased in openFDA with an initial pilot program involving reports of drug adverse events and medication errors that have been submitted to FDA from 2004 to 2013. Previously, the data were only available through difficult-to-use reports or Freedom of Information Act requests.
According to FDA, the adverse events data made available under this initiative do not contain any data that could potentially be used to identify individuals or other private information. The pilot will later be expanded to include the FDA’s databases on product recalls and product labeling.
“Through this new and novel approach to data organization, these reports will be available in their entirety so that software developers can build tools to help signal potential safety information, derive meaningful insights, and get information to consumers and healthcare professionals in a timely manner,” said Taha Kass-Hout, MD, the FDA’s chief health informatics officer. “OpenFDA offers a scalable platform that can be easily searched and queried across many distinct datasets, can be easily redeployed or altered to fit a variety of purposes, and provides an innovative public data search and analytics solution.”
Source: FDA.gov
Novo Nordisk Hemophilia Treatment Gets Positive Opinion from CHMP
October 23rd 2024As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.