Regulatory Considerations in the Development of Therapies for Diabetic Nephropathy and Related Conditions

  • G. Alexander Fleming
Chapter

Abstract

The importance of regulation in the drug development process is well appreciated, but the principles and practices of the major regulatory agencies overseeing therapeutic development are much less understood even by well-informed academicians. This chapter is intended to provide a better understanding of the regulatory framework and processes that are pertinent to therapeutic development in general and the advancement of therapies for diabetic nephropathy and related conditions in particular. While this attempt reflects the perspective and focus of a former evaluator in the United States Food and Drug Administration (FDA), the important roles of other national and supranational authorities cannot be over-stated for what has become a shared, global enterprise.

Keywords

Diabetic Nephropathy Surrogate Outcome Aldose Reductase Inhibitor Therapeutic Development Advanced Glycation Endproducts 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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Copyright information

© Springer Science+Business Media New York 2000

Authors and Affiliations

  • G. Alexander Fleming
    • 1
  1. 1.Regulatory AffairsWorldwide Clinical TrialsUSA

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