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# Guidance on Osteoporosis Drugs
- URL: https://www.fdaweb.com/guidance-on-osteoporosis-drugs/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135939

Federal Register Notice: FDA is making available a draft guidance for industry entitled *Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment*. It provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. It also discusses the nonclinical development of biopharmaceuticals (e.g., recombinant proteins and monoclonal antibodies). To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM506366.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-14/pdf/2016-13988.pdf?ref=fdaweb.com)