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US FDA requires boxed warning and REMS for botulinum toxin products

This article was originally published in SRA

Executive Summary

Prompted by reports of serious adverse events, the US Food and Drug Administration is requiring safety labelling changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy, for all botulinum toxin products1. Manufacturers are required to submit the requested safety labelling changes, including the boxed warning and a Medication Guide, to the FDA by the end of May, or to provide a reason why they do not believe such changes are necessary.

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