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Causation Disclaimers Should Be In Adverse Event Reports Submitted To FDA

 
• By Elizabeth Crawford

Dietary supplement firms should use a script for receiving AERs and establish review protocols to ensure serious events are reported to FDA, recommends attorney Claudia Lewis. She detailed best practices for supplement AERs at a recent American Conference Institute conference.

When submitting mandatory serious adverse event reports to FDA, dietary supplement firms should include an assessment of the possible cause of the adverse event and a disclaimer that the report is not an admission the product caused the event, advises attorney Claudia Lewis.

While the submission of an AER is not an indication of causation, FDA encourages supplement firms to include with reports...

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