Breakthrough-Therapy Designation - An FDA Perspective
N Engl J Med
.
2018 Apr 12;378(15):1457-1458.
doi: 10.1056/NEJMc1801222.
Authors
Jacqueline Corrigan-Curay
1
,
Amy E McKee
1
,
Peter Stein
1
Affiliation
1
Food and Drug Administration, Silver Spring, MD jacqueline.corrigan-curay@fda.hhs.gov.
PMID:
29641963
DOI:
10.1056/NEJMc1801222
No abstract available
Publication types
Letter
MeSH terms
Drug Approval / legislation & jurisprudence*
Drug Discovery
Drugs, Investigational / therapeutic use*
Government Regulation
Humans
United States
United States Food and Drug Administration*
Substances
Drugs, Investigational