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Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, Nonalcoholic Steatohepatitis (NASH) and Other Cardiometabolic Disorders

  • G. Alexander FlemingEmail author
  • Brian E. Harvey
Chapter

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 available published and web-based resources that describe current regulatory expectations and requirements. Though the Food and Drug Administration (FDA) is emphasized for illustrative purposes, the importance of the European Medicines Agency (EMA) and other regional authorities should not be minimized. Some relevant differences between EMA and FDA are also discussed. With emphasis on early studies, selected regulatory considerations are presented for developing diabetes, anti-obesity and lipid-lowering therapies towards existing therapeutic indications. Regulatory and clinical trial considerations are provided for developing novel therapeutic indications including those for nonalcoholic steatohepatitis (NASH) and related disorders.

Keywords

Diabetes Obesity Hyperlipidemia Lipid-lowering therapies Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis (NASH) Food and Drug Administration (FDA) Patient-focused drug development 

Notes

Acknowledgements

The authors thank Charles Alexander, Frances Mielach, Asoke Mukherjee, Lynn Schaich, Thomas Seoh, and Knut Zellerhoff for helpful suggestions and Brandon Jones for editorial assistance.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.KinexumHarpers FerryUSA
  2. 2.Global Liver InstituteWashington, DCUSA

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