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

Issue Date: August 15, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical, Pharmacology/Toxicology
Status: Final

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

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.

Download the Guidance Document

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