FDA proposes mandatory e-safety reporting rules

January 2010
Clinical Trials Administrator;Jan2010, Vol. 8 Issue 1, p11
This article focuses on a proposal by the U.S. Food and Drug Administration (FDA) to amend postmarket safety reporting regulations to require manufacturers and other facilities to submit reports in an electronic format. Both electronic medical device adverse event (AE) reporting and electronic and biologic product adverse experience reporting are covered by the proposed rules. FDA officials claim a paper format hinders the Center for Devices and Radiological Health's ability to review safety data quickly.


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