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FDA, EMA improving adverse reaction tracking

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/BrianAJackson)
(Image: iStock/BrianAJackson)

Related tags: Food and drug administration

The FDA has launched a new adverse event reporting system and the EMA’s updated EudraVigilance platform is set to go live later this year.

The US Food and Drug Administration (FDA) has launched a new online tool​ that enables users to search the FDA Adverse Event Reporting System (FAERS).

The new search tool improves access to data for consumers, providers, and researchers, according to the FDA.

(Image: FAERS screenshot)
(Image: FAERS screenshot)

"Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA​," commented FDA Commissioner Scott Gottlieb, M.D. in the release.

EMA update

The European Medicines Agency (EMA) EudraVigilance​ tracks adverse reactions to medicines authorized or being studied in clinical trials in the European Economic Area (EEA).

According to the agency, the new system – which is set to go live on November 22, 2017 – will feature enhanced reporting and analysis of suspected adverse reactions “to support a better safety monitoring of medicines and a more efficient reporting process for stakeholders​.”

Updating to the new version of EudraVigilance will involve the transfer of more than 11m individual case safety reports from clinical trials and post-authorization.

Related topics: Markets & Regulations

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