The FDA Breakthrough-Drug Designation — Four Years of Experience
The FDA Breakthrough-Drug Designation — Four Years of Experience
About this item
Full title
The FDA Breakthrough-Drug Designation — Four Years of Experience
Author / Creator
Publisher
United States: Massachusetts Medical Society
Journal title
The New England journal of medicine, 2018-04, Vol.378 (15), p.1444-1453
Language
English
Formats
Publication information
Publisher
United States: Massachusetts Medical Society
Subjects
More information
Scope and Contents
Contents
In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of medications with potential to provide substantial improvement over existing treatments. The authors review the first 4 years of experience with this program.
Alternative Titles
Full title
The FDA Breakthrough-Drug Designation — Four Years of Experience
Authors, Artists and Contributors
Author / Creator
Identifiers
Primary Identifiers
Record Identifier
TN_cdi_proquest_miscellaneous_2024467433
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_2024467433
Other Identifiers
ISSN
0028-4793
E-ISSN
1533-4406
DOI
10.1056/NEJMhpr1713338
