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AdvaMed Asks US FDA To Add Causality, RWE To Safety-Reporting Draft Guidance

The medtech lobby group wants to see clarification on how causality is addressed in the reports and for them to also apply to real-world evidence trials.

US FDA entrance

AdvaMed has asked the US Food and Drug Administration to make a number of clarifications and changes to its recently proposed safety reporting draft guidance, including adding a section to reports on addressing causality.

In September, the FDA published a draft guidance for medical device and pharmaceutical trial investigators to report safety issues with devices they are studying. The agency noted that 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

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