Skin ulcer and burn wound guidance
This article was originally published in The Gray Sheet
Executive Summary
Final FDA guidance for ulcer and burn wound product development advises manufacturers on clinical trial design, labeling claims, outcome measures and special considerations for preclinical development. It includes information on outcome measures for pain amelioration and temporary dressings, plus recommendations for evaluation of efficacy outcomes that were not addressed in a June 2000 draft document. Published in the Federal Register June 1, the document provides clarification on accelerated would closure and debridement outcomes, derived from comments on the draft...