Regulatory aspects of the development of drugs for metabolic bone diseases - FDA and EMA perspective.

Regulation of medicines involves complex scientific and public health policies which are reflected in the regulatory approaches used by the European Medicines Agency and the United States Food and Drug Administration for the approval of products developed for metabolic bone diseases. For osteoporosis therapies, utilized by many patients, the approaches and existing guidance for product development of both agencies are similar; confirmatory studies for the approval of osteoporosis products can rely on well-defined efficacy outcome parameters. Therapeutics for rare bone diseases, a rapidly expanding area, often require an individualized regulatory approach. This review outlines key aspects of these regulatory approaches applied by the two agencies for products for metabolic bone diseases.