Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders

  • G. Alexander Fleming


Advancing therapeutic discoveries through early clinical studies benefits from a working knowledge of regulatory history, practices, provisions, procedures, and controversies. This chapter aims to supplement readily available published and web-based resources that describe regulatory expectations and requirements. Though the Food and Drug Administration is emphasized, the importance of the European Medicines Agency (EMA) and other major authorities is acknowledged. Some relevant differences between EMA and the Food and Drug Administration (FDA) are discussed. With emphasis on early studies, selected regulatory considerations are presented for developing diabetes, anti-obesity, and lipid-lowering therapies toward existing therapeutic indications. Novel therapeutic indications that have reasonable prospects for approval are also described. Interpretations and preferences expressed reflect the author’s experience as an endocrinologist and an FDA representative, educator, and reviewer responsible for approval of the first statin and insulin analog, metformin, and other metabolic products.


European Medicines Agency (EMA) Food and Drug Administration (FDA) Good Clinical Practice (GCP) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Investigational New Drug (IND) Institutional Review Boards (IRB) Medical Dictionary for Regulatory Activities (MedDRA) New Drug Application (NDA) Orphan drug Study design 


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Copyright information

© Springer-Verlag London 2015

Authors and Affiliations

  1. 1.Kinexum Services LLCHarpers FerryUSA

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