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