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Health Agencies Update
July 23/30, 2014

FDA Opens Adverse Event Data

Author Affiliations

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;312(4):328. doi:10.1001/jama.2014.9120

The US Food and Drug Administration (FDA) has launched a new initiative to make it easier for researchers, web developers, and others to access and build interactive tools based the FDA’s Adverse Events Reporting System data.

The openFDA ( initiative is part of a larger effort to make Department of Health and Human Services data more accessible. Currently, the adverse event reports are publicly available (with identifying data excluded). Accessing the data, however, requires a time-consuming Freedom of Information Act request. In addition, the FDA typically provides the information in a report that may not be easy to use.

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