Stem Cell-Food and Drug Administration (FDA) part 5

Stem cell 4

 

Children should not be enrolled in a clinical investigation  unless necessary to answer an important scientific question about the health and welfare of children

  • Study design capable of answering question
  • Practical application (determine type and timing of clinical studies required  for establishing “safe  and effective” pediatric use)
  • Objective “public health benefit” for children
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