The FDA regulatory process for drug and genetic diagnostic test approvals.
Bristow
Michael R
MR
Department of Medicine, University of Colorado, Denver, USA.
Hiatt
William R
WR
D057069:Diagnostic Test Approval; D017277:Drug Approval; D005820:Genetic Testing / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration