U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment May 2018

Final
Docket Number:
FDA-2005-D-0461
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

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:

Dockets Management
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.