> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Acne Vulgaris Drug Effectiveness
- URL: https://www.fdaweb.com/guide-on-acne-vulgaris-drug-effectiveness/
- Published: 2018-05-21T12:00:00.000Z
- Updated: 2026-09-15T00:06:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141485

FDA has made available a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071292.pdf?ref=fdaweb.com) on “Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.” The document provides recommendations for establishing clinical effectiveness based on FDA’s assessment of issues raised in the review of clinical trials for such products. The agency says it does does not address systemic retinoid therapies because they may not have appropriate risk-benefit profiles for non-nodular acne therapy. Sponsors are advised to discuss development programs for systemic retinoids with the review division before trial initiation. The guidance also does not address clinical safety, clinical pharmacokinetics, nonclinical issues, or chemistry, manufacturing, and controls issues.