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.
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 (January 1997)
• Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
• Study of Drugs Likely to be Used in the Elderly (November 1989)
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
34 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required…