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Thursday, 27th May 2010

FDA and NIH Launch Electronic Safety Reporting Portal

FDA and NIH Launch Electronic Safety Reporting Portal

The Food and Drug Administration and the National Institutes of Health today launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the Web site can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers can also use the site to report problems with pet foods and pet treats.

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:

  • 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.

+ Safety Reporting Portal
+ FDA Safety Reporting
+ Reportable Food Registry for Industry
+ Reporting a Problem with Veterinary Products

Source: U.S. Food and Drug Administration


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