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GUIDANCE DOCUMENT

Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment October 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-1181
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for systemic drugs to support an indication for the treatment of ABSSSI. This guidance defines ABSSSI as cellulitis/erysipelas, wound infection, and major cutanenous abscess.

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All written comments should be identified with this document's docket number: FDA-2013-D-1181.

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