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# Nonclinical Osteoporosis Drug Study Guide
- URL: https://www.fdaweb.com/nonclinical-osteoporosis-drug-study-guide/
- Published: 2019-08-16T12:00:00.000Z
- Updated: 2026-09-15T01:44:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144787

*Federal Register*: FDA has made available a final guidance entitled “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment.” The document provides recommendations on designing nonclinical bone quality studies to support the approval of drugs and biologics (e.g., recombinant proteins and monoclonal antibodies) for treating osteoporosis. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-08-15/pdf/2019-17513.pdf?ref=fdaweb.com).