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

wound for which a product is intended (e.g., venous This document is intended to provide guidance1 to sponstasis ulcer, diabetic foot ulcer, pressure ulcer, burn sites, sors on the development of drugs, biological products, donor sites). Wounds differ pathophysiologically, making and devices2 to treat chronic cutaneous ulcer and burn it difficult — if not impossible — to generalize results wounds. The guidance contains recommendations about obtained from a trial conducted in patients with one type labeling claims, outcome measures, and trial design, as of wound to those with another wound type. Separate well as special considerations for preclinical developsafety and efficacy data will generally be necessary for ment. each wound type for which an indication is sought.