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# FDA Draft Guide on Osteoporosis Nonclinical Development
- URL: https://www.fdaweb.com/fda-draft-guide-on-osteoporosis-nonclinical-development/
- Published: 2016-06-13T12:00:00.000Z
- Updated: 2026-09-14T21:09:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135917

FDA has released a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM506366.pdf?ref=fdaweb.com) on “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment” that provides recommendations for designing a nonclinical development program to support approval for such drugs. “In addition to the pharmacology and toxicology studies required to support development of a new drug or biologic, long-term nonclinical studies to evaluate effects on bone quality in adequate animal models and including bone-specific pharmacologic and toxicologic endpoints are needed,” the agency says. The document also discusses the nonclinical development of biopharmaceuticals (e.g.,recombinant proteins and monoclonal antibodies).