On the development of antifungal agents: perspective of the U.S. Food and Drug Administration.

Abstract

As medical advances have prolonged the lives of patients with cancer, recipients of organ transplants, and patients with AIDS, there has been a marked increase in the number of fungal infections. Because of the known toxicity associated with amphotericin B, which has been the mainstay of therapy for systemic fungal infections, there has been a pressing need for regimens that are more effective and less toxic and that are more easily complied with by patients. This article provides a brief overview of the regulatory process of drug approval and discusses issues specific to the design of clinical trials for the treatment of systemic fungal diseases.