March 11, 2016

A Crystal Ball for FDA Action: How we Validated RxSignal

We are pleased to report that our latest major publication, “A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports” was released this week in the esteemed journal “Drug Safety.”  It was published as an online-first feature and will also appear in the April copy of the print version of Drug Safety.

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March 3, 2016

Watson Health is the Ultimate Data Parasite


One year after its birth, the ultimate data parasite has come of age by latching on to a $3 billion host. It is big, blue, pretty good at Jeopardy, and if you were to believe the data detractors, utterly useless.

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October 2, 2014

FAERS - Myths vs. Realities

 

The use of the FDA’s Adverse Event Reporting System (FAERS) for broad post-approval drug safety studies has long been curtailed due to three assumed limitations of the dataset. AdverseEvents has systematically set out to debunk all three of these myths through the use of peer-reviewed studies in major academic journals. This blog article summarizes our findings and we invite you to review our complete journal articles for more details.

 

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July 18, 2014

OpenFDA – the Good, the Bad, and the Ugly


On June 3rd, the FDA launched OpenFDA, in an attempt to take large internal datasets and make them more accessible and usable by the developer and business community.

OpenFDA is delivered in a search-based API that should enable software developers to more easily build applications based on adverse event data from the FDA Adverse Event Reporting System (FAERS) dataset for the period 1/1/2004 to 6/30/3013. The FDA has announced plans to add device and food adverse events data to the framework, along with structured product labeling and recall data (update: drug and device recall data was added on July 16). 

The launch was heralded with the sort of buzz and hoopla usually reserved for a major product launch from a Silicon Valley startup. I decided to hold off on any analysis and opinion until now to give our team the needed time to look through the system thoroughly.

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March 28, 2014

FDA Releases Updated Drug Safety Data – Announces OpenFDA… Now hold your applause


Creating actionable analytics around the big data set provided through the FDA Adverse Event Reporting System (FAERS) is the backbone of the AdverseEvents Explorer software. Given the infrequency of releases in 2013, you can imagine how excited we were when we heard the news that Q1 2013 data were finally posted for download. While probably not surprising, self-described data geeks do get excited about data.

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December 5, 2013

How Are Post-Approval Adverse Drug Event Data Obtained?


The centralized computerized information database for post-marketing drug safety surveillance is the FDA Adverse Event Reporting System (FAERS), which is currently growing by approximately 800,000 new cases per year. In 1993, FAERS (then referred to as AERS) launched with a simple, and worthy, goal: facilitate the reporting of post-approval ADEs. For healthcare professionals and consumers reporting is voluntary, but drug manufacturers must report all known ADEs to the FDA. In 2007, in order to enhance post-approval drug safety analysis even further, the FDA began to require drug companies to enact Risk Evaluation and Mitigation Strategies (REMS) to better manage, track, and report ADEs.

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