The FDA regulatory process for drug and genetic diagnostic test approvals
Clin Transl Sci
.
2008 Dec;1(3):188-9.
doi: 10.1111/j.1752-8062.2008.00066.x.
Authors
Michael R Bristow
1
,
William R Hiatt
Affiliation
1
Department of Medicine, University of Colorado, Denver, USA.
PMID:
20443847
PMCID:
PMC5350662
DOI:
10.1111/j.1752-8062.2008.00066.x
No abstract available
MeSH terms
Diagnostic Test Approval*
Drug Approval*
Genetic Testing / legislation & jurisprudence*
United States
United States Food and Drug Administration*