December 13, 2016

Adverse Events 101

Rick Kingston, President, Regulatory and Scientific Affairs

If you’re wondering exactly what constitutes an adverse event (AE), you’ve come to the right place. In general terms, an adverse event is an experience associated with the use of a product that is or could be considered adverse or unwanted. They typically fall into three categories:

  • Toxicology-related adverse events – When humans
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December 7, 2016

FDA Now Making Data Available from CFSAN’s Adverse Event Reporting System (CAERS)

As part of the FDA’s commitment to transparency, for the first time it has begun posting data from CFSAN’s Adverse Event Reporting System (CAERS) on FDA.gov here and through OpenFDA. It’s downloadable in ASCII format, which is amenable to automated querying.

The database contains information on adverse event and product complaint reports submitted to the FDA for Center for Food …