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FDA, MIH Launch Electronic Safety Reporting Portal

May 26, 2010
by root
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The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched the Safety Reporting Portal (SRP), a Web site that will eventually allow for the reporting of pre- and post- market safety data to the federal government.

As of its launch, SRP can currently be used to report safety problems related to foods, animal feed, animal drugs, and adverse events occurring on human gene transfer trials. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

The system is planned to eventually encompass other types of clinical trials, and also allow for reporting on safety problems that arise from products regulated by a broad array of federal agencies. The FDA sees this as the first step towards creating a common electronic reporting system that would allow an individual to file a single report to multiple agencies.

The FDA and NIH hope SRP will ultimately enhance the government’s systemic analysis of safety information to greater benefit public health.



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