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GUIDANCE DOCUMENT

Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry Guidance for Industry August 2019

Download the Final Guidance Document Read the Federal Register Notice
Final
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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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