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A Twenty Year Summary of FDA Animal Safety Testing of Contraceptive Steroids

  • Solomon Sobel
Part of the Reproductive Biology book series (PBTS)

Abstract

I think it is useful to present a little history. In 1962, the Kefauver-Harris Amendments were enacted and a new approach to the drug approval process was implemented. That approach included a formalized investigational new drug application. As part of that program there were suggestions made that certain preclinical tests be performed before the Phase I studies of the IND could be initiated.

Keywords

Breast Cancer Committee Member Drug Application Sensitive Model Molecular Entity 
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

© Plenum Press, New York 1986

Authors and Affiliations

  • Solomon Sobel
    • 1
  1. 1.Center for Drugs and Biologics Food and Drug AdministrationRockvilleUSA

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