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

Assure Progesterone Progestin Provera Norethindrone 

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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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