miércoles, 30 de octubre de 2019

The FDA is expanding a controversial tool

The Readout
Damian Garde

The FDA is expanding a controversial tool

Remember when someone accidentally reported a clinical trial patient’s symptoms to a public FDA adverse event tracking system and sent Sarepta’s shares crashing this summer?

The FDA may soon require companies to submit adverse event reports to that system on purpose — though they still won’t be intended for the public’s eyes.

The agency announced yesterday that it would like to start accepting serious, drug-related side effect reports from clinical trials to its Adverse Event Reporting System, otherwise known as FAERS.

Companies already have to report serious side effects that happen during trials to the agency, but today those reports are sent as e-mail attachments or (gasp) on paper. Requiring companies to report side effect data to FAERS instead will allow the agency to better compare safety reports from before and after a drug’s approval, the agency says.

However, that requirement won’t take effect for years. The FDA’s guidance is still just a draft — and even after it's finalized, companies will have two years of voluntary reporting to adjust to the new system.

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