May 24, 2010
New web site provides entry to three key FDA safety reporting systems
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) today launched a new Web site for industry to report food safety problems or adverse events involving FDA-regulated foods and animal feeds, pet foods and pet treats, animal drugs, and human gene transfer research. The new site, called the Safety Reporting Portal (SRP), is the next step in FDA’s effort to expand online reporting options.
“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 Margaret A. Hamburg, Commissioner of Food and Drugs. “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 SRP, which opened today at www.safetyreporting.hhs.gov, includes:
- Reportable Food reports for food industry facilities and public health officials when they have determined that there is a reasonable probability that an article of food or animal feed will cause serious adverse health consequences or death to humans or animals;
- A Pet Food report where consumers and veterinary personnel can report adverse events or product problems with pet foods and pet treats;
- An Animal Drug Adverse Event report where animal drug makers and distributors can rapidly report to FDA about issues that may affect animal safety; and,
- An Adverse Event report for biomedical researchers involved in human gene transfer clinical trials.
The SRP provides new more user-friendly conveniences that reporters to the RFR did not have with the former RFR portal: if submitters establish a free account, they will be able to save draft, partially completed, or submitted reports; have new reports pre-populated with their contact information and amended reports pre-populated with all the information from their original submission; and view any previous submissions they have made to the Safety Reporting Portal. These changes respond to concerns industry has raised since the original RFR opened last September.