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Wound treatment products

This article was originally published in The Gray Sheet

Executive Summary

FDA draft guidance released June 28 requests comments on appropriate claims, endpoints and assessment tools for products to treat venous stasis ulcers, diabetic foot ulcers, pressure ulcers and burn wounds. The guidance specifies the endpoints necessary to support claims for "complete" or "accelerated" wound closure, facilitation of surgical closure, improved quality of healing, wound infection control, debridement and wound pain control
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