FDA Forming Consortium to Study Gene Biomarkers Linked to Serious Adverse Events | GenomeWeb
NEW YORK (GenomeWeb News) — The US Food and Drug Administration is creating a consortium with members of the pharmaceutical industry and academia that aims to observe how genetic biomarkers contribute to serious adverse events, according to an NIH report and people familiar with the project.
The FDA’s decision to form the initiative, called the Serious Adverse Events Consortium, comes at a time when a chorus of critics increasingly blames the agency for not doing enough to ensure the safety of marketed drugs.

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