Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment May 2018
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to provide recommendations to industry for establishing clinical effectiveness of drugs for the treatment of acne vulgaris (acne).2 The recommendations in this guidance are based on the FDA’s assessment of issues raised in the review of clinical trials for acne.
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-2005-D-0461.