The FDA and NIH have unveiled a new website that will one day be the central place for reporting on safety issues with foods, drugs, devices, and many other products. Currently to properly report on a product requires submitting forms to different agencies and the new website will try to streamline and centralize the process.
From FDA’s press release:
The new Web portal includes different features for different types of reporting:
Reportable Food Registry: Industry will have a more user-friendly electronic portal for submitting reportable food reports that are required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals. Pets: Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats. Animal drugs: Animal drug manufacturers can report adverse drug events associated with animal drugs. Clinical Trials: 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 agency to satisfy reporting requirements for investigational new drugs.
In the future, the 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 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.
Link: Safety Reporting Portal…
Press release: FDA and NIH Launch Electronic Safety Reporting Portal…