FDA Unveils Safety Reporting Portal

The Food and Drug Administration and National Institutes of Health have launched the Safety Reporting Portal to enable organizations and consumers to submit complaints or concerns about FDA-regulated foods, drugs, veterinary products and clinical trials, in pre- and post-market stages.

The portal will aid in improving the nation's surveillance system, says FDA Commissioner Margaret Hamburg. The portal includes a reportable food registry for industry and public health officials to report issues, an animal drugs registry for manufacturers to report, a pets registry for pet owners and veterinarians to report, and a clinical trials registry for biomedical researchers involved in human gene transfer trials to report.

The portal eventually will accept reports of safety problems arising from other types of clinical trials and other products regulated by multiple federal agencies. Consequently, the portal is a first step toward a common electronic reporting system that will offer one-stop shopping to enable the filing of a single report to multiple agencies that would have an interest in the same adverse event.

The portal is available at https://www.safetyreporting.hhs.gov.

--Joseph Goedert