EN PL

FDA: Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment

26.08.2010
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), impetigo, and minor cutaneous abscesses. 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 treatment of ABSSSI, and topical or systemic drugs to support an indication for treatment of impetigo or minor cutaneous abscesses.