The FDA published a guidance for industry on developing drugs and biologic treatments for ulcers and burn wounds.
The guidance provides recommendations on developing products to treat chronic cutaneous ulcers -- including venous stasis ulcers, diabetic foot ulcers and pressure ulcers -- and burn wounds. It includes general guidance on clinical trial design, such as recommendations for trial design, labeling claims, outcome measures and special considerations for preclinical development and manufacturing.
The guidance defines a chronic cutaneous ulcer 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"; and a burn wound as "a cutaneous wound induced by thermal, chemical or electrical injury."
The "Guidance for Industry on Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment" can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1318-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1318-gdl0002.pdf).
