Johnson & Johnson Pharmaceutical Research & Development has announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.