- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2000-D-0037.