• Regulatory NewsRegulatory News

    OpenFDA Releases Huge Trove of Medical Device Data

    On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform. Background The openFDA initiative was originally born from an order from the White House , which called for federal agencies to implement a new " digital strategy " to make government information more accessible to the public. The strategy focused on creating APIs – not active pharmaceutical ingredients, but application program interfaces – that ...
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    precisionFDA: A Crowd-Sourced, Cloud-Based Platform for Precision Medicine

    The US Food and Drug Administration (FDA) has announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, to enable developers of genomic sequencing diagnostics to share data and methodologies. precisionFDA In a post to FDA Voice Wednesday, FDA Chief Health Informatics Officer Taha Kass-Hout and Policy Advisor for the Office of In Vitro Diagnostics and Radiological Health David Litwack laid out the plan and goals for precisionFDA. The new platfo...
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    One Year Into 'openFDA'

    In June 2014, the US Food and Drug Administration (FDA) launched a technology-driven "openFDA" initiative to make it easier to access and interpret the agency's publicly available data. Background The openFDA initiative was originally born from an order from the White House , which called for federal agencies to implement a new " digital strategy " to make government information more accessible to the public. The strategy focused on creating APIs – not active pharmace...
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    Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015

    The number of medical device recalls appears to have plunged during the first quarter of 2015, a review of the US Food and Drug Administration's (FDA) data by Regulatory Focus has revealed. FDA has since last year been publishing data about its drug and device recall reports through its new open data platform, openFDA . The data make it much easier to assess trends in enforcement measures, including the number of recalls classified by FDA. A review of FDA's device r...
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    New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes

    US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program. Background The openFDA initiative was born from a May 2013 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public. At th...
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    FDA Wants to Make Product Recalls Easier to Track

    A little more than a month after first launching its long-anticipated openFDA project, the US Food and Drug Administration (FDA) has announced that it hopes the project can do for product recalls what it has already done for adverse event data. Background The openFDA initiative was born from a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and...
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    FDA Launches Big Data 'openFDA' Initiative, Giving Public Easier Access to Safety Information

    The US Food and Drug Administration (FDA) has launched a long-awaited technology initiative intended to free regulatory data that was once difficult to obtain and harder still to make sense of. Background The initiative, known as openFDA, comes in the wake of a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public....