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Online safety reporting portal launched

The US Food and Drug Administration and the National Institutes of Health have launched a new website for reporting safety data

The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched a new website for reporting safety data to the US federal government.

It is hoped the Safety Reporting Portal (SRP) will streamline the process of reporting product safety issues to the FDA and NIH, with manufacturers, healthcare professionals, researchers, public health officials and consumers all able to submit an online safety report.

Currently, the site can be used to report safety problems relating to food (both human and animal), animal drugs as well as adverse events occurring on clinical trials involving human gene transfer.

Consumers can also report problems regarding pet foods and pet treats.

The website will eventually allow for safety problems with other clinical trials to be reported, as well as encompassing safety issues from products regulated by a broad array of federal agencies, such as the Environmental Protection Agency (EPA).

The FDA said it sees the site as the "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."

Organisations and individuals in certain professional roles, including drug manufacturers, researchers and food manufacturers, may be required by law to submit safety reports.

Safety issues or harmful effects noticed in products by consumers, health professionals, and public health officials can be raised in voluntarily submitted reports.

"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 FDA commissioner, Margaret A Hamburg. "We will now be able to analyse human and animal safety-related events more quickly and identify those measures needed to protect the public."

1st June 2010

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