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FDA rules say e-report adverse drug, device events


By Andis Robeznieks
Posted: August 20, 2009 - 11:00 am ET
Tags:

The Food and Drug Administration today proposed new rules that would require adverse events reports related to approved devices, drugs and biologic products to be submitted electronically.

Currently, reports are received both electronically and on paper, with the paper reports requiring a manual input of the information into FDA databases. The FDA has been working on a pilot program since 2000 to allow drug and device manufacturers to electronically submit reports, and the FDA said in a news release that this has enabled its staff to more rapidly review safety data and identify emerging problems.

The FDA predicted that the move to electronic reporting, which has been discussed for years, will result in reduced industry costs and better communication between the FDA and other regulators.

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