Subject: The Safety Reporting Portal:FDA & NIH

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

For more detail see:

http://tinyurl.com/libtech101