Regulatory Focus™ > News Articles > FDA Seeks Feedback on Postmarketing Adverse Event Drug Reporting

FDA Seeks Feedback on Postmarketing Adverse Event Drug Reporting

Posted 19 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is looking for feedback regarding its postmarketing adverse drug experience reporting system, including ways to make the system more efficient and less burdensome for manufacturers.

In a 20 March Federal Register posting, FDA said, "Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the product's labeling (such as adding a new warning), decisions about risk evaluation and mitigation strategies or the need for postmarket studies or clinical trials, and when necessary, to initiate removal of a drug from the market."

Adverse event reports take a large amount of time, taking roughly 60 hours to complete each Section 314.80(c)(2), totaling approximately 912,000 hours per year for the entire pharmaceutical sector. An additional 6.4 million hours are spent on recordkeeping duties by the pharmaceutical industry.

Any small increases in efficiency would therefore generate huge savings in time across the sector.

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Read more:

FDA - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Postmarketing Adverse Drug Experience Reporting

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