Adverse Event Reports Go Digital Only

October 2009
Pharmaceutical Representative;Oct2009, Vol. 39 Issue 10, p9
The article reports on the proposal of the Food and Drug Administration (FDA) to require pharmaceutical companies to submit post-marketing adverse event reports in an electronic format in the U.S. The FDA's proposal aims waste on paper submissions and identify safety concerns as well as share safety information. The Center for Drug Evaluation and Research of the FDA allows drug companies to submit forms in an electronic format through a pilot program.


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