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Regulatory aspects of the development of drugs for metabolic bone diseases – FDA and EMA perspective
Author(s) -
Kehoe Theresa,
Blind Eberhard,
Janssen Heidi
Publication year - 2019
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.13791
Subject(s) - regulatory agency , regulatory science , medicine , food and drug administration , drug development , osteoporosis , agency (philosophy) , intensive care medicine , drug , pharmacology , risk analysis (engineering) , political science , pathology , public administration , philosophy , epistemology
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.