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FDA and NIH Launch Electronic Safety Reporting Portal

The FDA and the NIH launched a new website that, when fully developed, will provide a mechanism for the reporting of pre and post market safety data to the federal government. The new site, called the Safety Reporting Portal (SRP) will provide  access to online reporting to analyze human and animal safety related events needed to protect the public.

The new Web portal includes different features and types of reporting but specifically includes clinical trials.  The new system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies.  This is a 1st 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. Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agencies to satisfy reporting requirements for investigational new drugs.

Just as important, the portal will ultimately enhance the FDA and NIH’s systematic analysis of safety information.  In the meantime, the new portal redirects individuals who want to submit reports about other products regulated by FDA, the U.S. Department of Agriculture, Environmental Protection Agency or the Consumer Product Safety Commission to the appropriate contact.