The purpose of this guidance is to provide recommendations to industry for designing nonclinical studies to support the approval of drugs intended for the treatment of osteoporosis. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the nonclinical development program for biopharmaceuticals to treat osteoporosis.
We recommend sponsors review the following guidances for industry before initiating clinical trials of drugs intended to treat osteoporosis:
- General Considerations for the Clinical Evaluation of Drugs
- Clinical Evidence of Effectiveness for Human Drug and Biological Products
- Study of Drugs Likely to be Used in the Elderly