What is data mining?

"Data mining" is a broadly used term. With regard to FDA, data mining refers to the use of complex data analytics to discover patterns of associations or unexpected occurrences ("signals") in large databases. When such signals are identified, they can then be evaluated for potential intervention as appropriate, such as further assessment ("signal refinement"), labeling revisions, and hypothesis testing studies. Much of the data mining work at FDA involves detecting safety signals among adverse events reported to the Agency.

This webpage will provide information on data mining initiatives at FDA.