Saturday, May 29, 2010

FDA and NIH Launch Safety Reporting Web Site

Kate Johnson

May 25, 2010 — A new Web site aimed at streamlining reporting and surveillance of safety and adverse events has been launched by the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the agencies announced yesterday.

"The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the nation's health," FDA Commissioner Margaret A. Hamburg said in a news release.

The Safety Reporting Portal is part of the FDA's MedWatch Plus initiative. Its initial focus is primarily FDA-regulated foods (except dietary supplements and infant formula), as well as animal drugs and food and human gene transfer clinical trials. The FDA's preexisting MedWatch program will continue to focus on drug and medical device safety and adverse event reporting.

"The two systems are very similar and, over time, will merge into 1 system," Patricia El-Hinnawy, a press officer with the FDA, told Medscape Medical News. The Safety Reporting Portal will eventually expand to allow for mandatory reporting of serious events related to dietary supplements, as well as other clinical trials and products. In the meantime, it redirects traffic relating to these issues to the appropriate reporting sites.

When fully developed, the Web site will provide a mechanism for industry, healthcare professionals, and consumers to report a broad range of both pre- and postmarketing information to the federal government.

"This is the first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event," the FDA notes in a news release.

In addition, the portal is intended to enhance the government's surveillance capabilities. "We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public," Dr. Hamburg said.

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Source: Medscape

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