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Facial Implant Panel Endorsement Masks Study Bias Concerns

This article was originally published in The Gray Sheet

Executive Summary

Potential biases resulting from the use of patients as their own controls within Q-Med's Restylane pivotal trial drew criticism during FDA panel review of the hyaluronic acid-based dermal filler Nov. 21

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Hylaform approved for wrinkles

Inamed will commence shipments "immediately" of the Genzyme-made hyaluronic acid dermal filler under a marketing agreement. PMA approval announced April 22 does not require a pre-treatment skin test, Inamed notes. The product will be priced competitively with rival Medicis' filler Restylane, approved in December (1"The Gray Sheet" Dec. 15, 2003, In Brief). Both fillers received approvable-with-conditions recommendations from FDA's General & Plastic Surgery Devices Panel in November (2"The Gray Sheet" Dec. 1, 2003, p. 12)...

Hylaform approved for wrinkles

Inamed will commence shipments "immediately" of the Genzyme-made hyaluronic acid dermal filler under a marketing agreement. PMA approval announced April 22 does not require a pre-treatment skin test, Inamed notes. The product will be priced competitively with rival Medicis' filler Restylane, approved in December (1"The Gray Sheet" Dec. 15, 2003, In Brief). Both fillers received approvable-with-conditions recommendations from FDA's General & Plastic Surgery Devices Panel in November (2"The Gray Sheet" Dec. 1, 2003, p. 12)...

Inamed Stresses Hylaform Non-Inferiority; EU Clears Silicone Implant Safety

FDA's regulation of Genzyme's hyaluronic acid-based Synvisc osteoarthritic knee pain treatment could offer a precedent for labeling of the firm's Hylaform HA dermal filler

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