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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
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.

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2005-D-0461.

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