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The Regulation of Alpha-Fetoprotein Test Kits by the Food and Drug Administration

  • Stuart L. Nightingale

Abstract

In this paper, I will describe the path that the Food and Drug Administration (FDA) has taken to arrive at a decision in one of the most complex and challenging regulatory episodes in recent memory: the approval for marketing of a diagnostic product—the alpha-fetoprotein (AFP) test kit—for the prenatal detection of neural tube defects (NTDs).

Keywords

Amniotic Fluid Spina Bifida Neural Tube Defect Maternal Serum Public Hearing 
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

© Aubrey Milunsky and George J. Annas 1985

Authors and Affiliations

  • Stuart L. Nightingale
    • 1
  1. 1.Room 1495 (HFY-1)Food and Drug AdministrationRockvilleUSA

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