FDA and NIH Launch Electronic Safety Reporting Portal
The new site, called the Safety Reporting Portal (SRP), provides greater and easier access to online reporting.
"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," said Commissioner of Food and Drugs Margaret A. Hamburg. "We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public."
The new Web portal includes different features for different types of reporting:
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.
Just as important, the portal will ultimately enhance the government's systematic analysis of safety information, which will benefit public health. 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.
For more information
Safety Reporting Portal
FDA Safety Reporting
Media Inquiries: Pat El-Hinnawy, 301.796.4763, email@example.com
Consumer Inquiries: 888-INFO-FDA
-- 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.
SOURCE U.S. Food and Drug Administration
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