Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment." The purpose of this guidance is to provide recommendations to industry for designing nonclinical bone quality studies to support the approval of drugs and biologics (e.g., recombinant proteins and monoclonal antibodies regulated by the Center for Drug Evaluation and Research) intended for the treatment of osteoporosis.