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AdvaMed Asks US FDA To Add Causality, RWE To Safety-Reporting Draft Guidance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Food and Drug Administration to make a number of clarifications and changes to its recently proposed safety reporting draft guidance, including adding a section to reports on addressing causality.

In September, the FDA published a draft guidance for medical device and pharmaceutical trial investigators to report safety issues with devices they are studying.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

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