Docket Number:
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Guidance Issuing Office

Center for Drug Evaluation and Research

The purpose of this guidance is to provide recommendations to sponsors for the development of drugs, biological products, and devices2 to treat chronic cutaneous ulcer and burn wounds (i.e., wound-treatment products). The first part of this guidance addresses specific preclinical considerations. The guidance then addresses important considerations in clinical study design, including endpoint selection and manufacturing.

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All written comments should be identified with this document’s docket number: FDA-2000-D-0037.