Zdrowie i gospodarka · 28/06/2000

Draft Guidance for Industry on Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment." This draft document is intended to provide guidance on the development of drug and biological products intended to treat venous stasis ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds. The draft guidance contains recommendations about labeling claims, outcome measures, trial design, and special considerations for preclinical development.