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Dermal fillers on FDA’s radar

This article was originally published in The Gray Sheet

Executive Summary

Agency is putting together a "Post Market Issue Action Team" to address complaints about the long-term effects of dermal fillers, Peter Rumm, deputy director of general, restorative and neurological devices at the Office of Device Evaluation, says Sept. 17. Allergan gained expanded labeling in June for treatment effects lasting up to one year with its Juvederm Ultra and Juvederm Ultra Plus dermal fillers (1"The Gray Sheet" July 2, 2007, In Brief). BioForm Medical (Radiesse) and Artes Medical (ArteFill) are among other firms seeking longer-lasting indications

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