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FDA website for adverse event reports will encourage public participation

This article was originally published in Clinica

Executive Summary

The US FDA is developing a dedicated website that will serve as the sole repository for information about safety problems with medical devices, drugs, biologics, animal health products and food. The agency's plans were disclosed last week by deputy FDA commissioner Scott Gottlieb during a speech to a Bank of America healthcare conference in Washington. "The system will be easy to use so that the general public is encouraged to report incidents and is not deterred by the nature of the information requested," he explained. "Once collected, the consolidated information will make it easier for us to develop robust tools for screening reports."

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