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Zdrowie i gospodarka · 27/08/2010

Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment." The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor cutaneous abscesses. FDA's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of the changes in the definitions of ABSSSI and the recommendations for clinical drug development.

Source: Federal Register — Health and Human ServicesOpen original release →