Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
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Publisher
United States: Massachusetts Medical Society
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Language
English
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Publisher
United States: Massachusetts Medical Society
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Scope and Contents
Contents
The FDA's new “breakthrough therapy” designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.
Many people with serious or life-threatening illnesses for which there are no...
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Full title
Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
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TN_cdi_proquest_miscellaneous_1459154587
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_1459154587
Other Identifiers
ISSN
0028-4793
E-ISSN
1533-4406
DOI
10.1056/NEJMp1311439
