The Regulation of Alpha-Fetoprotein Test Kits by the Food and Drug Administration
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).
KeywordsAmniotic Fluid Spina Bifida Neural Tube Defect Maternal Serum Public Hearing
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