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Data Mining by FDA Product Centers:

Article: Use of Data mining at the Food and Drug Administration
Duggirala, HJ, et al. Use of data mining at the Food and Drug Administration. J Am Med Inform Assoc. 2016 Mar;23(2):428-34.

FDA Data Mining Council

Data Mining White Paper

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.



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