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Guidance for industry: Chronic cutaneous ulcer and burn wounds—developing products for treatment

Guidance for industry: Chronic cutaneous ulcer and burn wounds—developing products for treatment I. INTRODUCTION This document is intended to provide guidance to sponsors on the development of drugs, biological products, and devices to treat chronic cutaneous ulcer and burn wounds. The guidance contains recommendations about labeling claims, outcome measures, and trial design, as well as special considerations for preclinical development. For the purposes of this guidance, a chronic cutaneous ulcer is defined as a wound that has failed to proceed through an orderly and timely series of events to produce a durable structural, functional, and cosmetic closure. This document specifically addresses venous stasis ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds. The Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) within the FDA regulate products to treat cutaneous wounds. This document contains guidance applicable to the development of products regulated by any of the three Centers. Center‐specific issues and advice are noted where appropriate. II. CLAIMS A. General Considerations The claim (also referred to as the indication ) refers not only to the beneficial effects of a product, as determined through clinical investigations, but also to the type of wound for which a http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Wound Repair and Regeneration Wiley

Guidance for industry: Chronic cutaneous ulcer and burn wounds—developing products for treatment

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Wound Repair and Regeneration , Volume 9 (4) – Jul 1, 2001
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Publisher
Wiley
Copyright
Copyright © 2001 Wiley Subscription Services, Inc., A Wiley Company
ISSN
1067-1927
eISSN
1524-475X
DOI
10.1046/j.1524-475X.2001.00258.x
Publisher site
See Article on Publisher Site

Abstract

I. INTRODUCTION This document is intended to provide guidance to sponsors on the development of drugs, biological products, and devices to treat chronic cutaneous ulcer and burn wounds. The guidance contains recommendations about labeling claims, outcome measures, and trial design, as well as special considerations for preclinical development. For the purposes of this guidance, a chronic cutaneous ulcer is defined as a wound that has failed to proceed through an orderly and timely series of events to produce a durable structural, functional, and cosmetic closure. This document specifically addresses venous stasis ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds. The Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) within the FDA regulate products to treat cutaneous wounds. This document contains guidance applicable to the development of products regulated by any of the three Centers. Center‐specific issues and advice are noted where appropriate. II. CLAIMS A. General Considerations The claim (also referred to as the indication ) refers not only to the beneficial effects of a product, as determined through clinical investigations, but also to the type of wound for which a

Journal

Wound Repair and Regeneration – Wiley

Published: Jul 1, 2001

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