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Aggregating Adverse Events Data Should Be Sponsor Responsibility: FDA

The US agency has published a draft guidance outlining investigator and sponsor responsibilities in which it says sponsors are better suited to report aggregated adverse events to regulators.

FDA entrance sign 2016

The US Food and Drug Administration says while it should be the responsibility of trial investigators to keep track of adverse events, it should be the sponsor’s responsibility to track aggregated events data and report it to regulators.

The agency on 29 September published the draft guidance “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices,” in which it says investigators are required under law to...

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