Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015
N Engl J Med
.
2017 Apr 6;376(14):1386-7.
doi: 10.1056/NEJMc1700103.
Authors
Nicholas S Downing
1
,
Audrey D Zhang
2
,
Joseph S Ross
3
Affiliations
1
Brigham and Women's Hospital, Boston, MA.
2
New York University School of Medicine, New York, NY.
3
Yale School of Medicine, New Haven, CT joseph.ross@yale.edu.
PMID:
28379798
DOI:
10.1056/NEJMc1700103
No abstract available
Publication types
Letter
MeSH terms
Drug Approval / legislation & jurisprudence
Drug Approval / statistics & numerical data*
Europe
Time Factors
United States
United States Food and Drug Administration