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When did the FDA start the OpenFDA initiative?
Now, openFDA, an FDA Office of Health Informatics initiative launched in June 2014, is making it easier for researchers, scientists, web developers, and other FDA regulatory stakeholders to access and use those datasets in an open standard format.
How does OpenFDA improve access to datasets?
OpenFDA increases the efficiency and speed of accessing datasets by using cutting-edge, open-source code modules in a cloud-based environment. Nimble and user-centered product development methodologies are being used to expand and improve the platform and ensure user friendliness of its functions.
How is OpenFDA used in the scientific community?
Members of the scientific community can use openFDA to have their applications automatically query the data through application program interfaces (APIs). OpenFDA increases the efficiency and speed of accessing datasets by using cutting-edge, open-source code modules in a cloud-based environment.
What kind of data does the FDA have?
FDA has some of the world’s most valuable data stores about human health and medicine publicly available on its web site. The data are relevant and important to a wide range of groups. But the hurdles for a developer or researcher to use FDA data can be exceedingly high.
Is it possible to use FDA adverse event reports?
But the hurdles for a developer or researcher to use FDA data can be exceedingly high. For example, someone wanting to use a structured XML document of known adverse event reports for a particular drug would have to go through many complex steps to be able to obtain accurate results.
How often does the FDA meet with a sponsor?
How often the FDA meets with a sponsor varies, but this is one of two most common meeting points prior to submission of a new drug application. The other most common time is pre-NDA–right before a new drug application is submitted. Phase 3 studies begin if evidence of effectiveness is shown in Phase 2.