Docket Number:
FDA-2016-D-1273
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 intended for the treatment of osteoporosis.

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All written comments should be identified with this document's docket number: FDA-2016-D-1273.