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# New FDA AEMS Dashboard Needs Context, Transparency: Professors
- URL: https://www.fdaweb.com/new-fda-aems-dashboard-needs-context-transparency-professors/
- Published: 2026-04-21T12:00:00.000Z
- Updated: 2026-09-14T13:37:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161015

Two University of Pittsburgh pharmacy professors say FDA’s new Adverse Event Monitoring System (AEMS) dashboard was launched with a consequential omission. Writing in a column in *The Scientist*, the professors [say](https://www.the-scientist.com/the-fda-s-new-adverse-event-dashboard-more-data-doesn-t-mean-a-better-understanding-74385?ref=fdaweb.com) FDA “launched a powerful public-facing tool without building in the infrastructure to help people understand what the data can and cannot tell them. Without proper training, the adverse drug event information presented in the dashboard might mislead users and could lead to confusion over the safety of FDA-regulated products.”

The column notes that the change to the AEMS was made without opening a formal comment period where pharmacoepidemiologists and drug safety scientists could have weighed in before launch. “Solicited feedback on the operability of the public dashboard could prevent future misapplication and misrepresentation of the adverse drug event data presented in the new format,” it says.

The authors strongly suggest that FDA open a formal docket soliciting expert and client input on how AEMS data should be contextualized for non-specialist audiences, what additional limitations should be disclosed at the point of inquiry, and how the system’s artificial intelligence tools for signal detection should be documented and validated.

“Beyond the dashboard itself,” they conclude, “the agency needs to invest in active public education, including a webinar series explaining what adverse event reports can and cannot tell you, short video modules designed separately for clinicians and the public, and partnerships with professional societies to disseminate interpretive guidance. While democratizing data is important, doing it intentionally is essential. When people encounter raw adverse event counts without context, the most intuitive conclusion is often the wrong one. In a media environment built on speed, that misinterpretation can spread faster than any correction. The AEMS needs a careful user manual, and FDA is best suited to produce it.”