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

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Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development

Abstract

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.

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Notes

  1. 1.

    Ironically, the title could not be completely harmonized. The British/French spelling continues to be used in the official international title. FDA uses the American spelling.

  2. 2.

    FDA adopted the ICH reports as guidances to avoid the much longer period of time that would have been required to make these laws or regulations.

  3. 3.

    Pharmaceuticals and Medical Devices Agency of Japan

  4. 4.

    Development of biosimilar insulins and other peptide therapies has been the subject of much interest and regulatory activity. More information is found at the FDA website. See reference.

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  1. Kinexum Services LLC, Harpers Ferry, WV, USA

    G. Alexander Fleming BS, MD

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Correspondence to G. Alexander Fleming BS, MD .

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  1. Profil Institute for Clinical Research, Chula Vista, California, USA

    Andrew J. Krentz

  2. Profil Institute for Clinical Research, Chula Vista, California, USA

    Lutz Heinemann

  3. Profil Institute for Clinical Research, Chula Vista, California, USA

    Marcus Hompesch

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Fleming, G.A. (2015). Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders. In: Krentz, A., Heinemann, L., Hompesch, M. (eds) Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development. Springer, London. https://doi.org/10.1007/978-1-4471-4920-0_12

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