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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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N Engl J Med 2013 Nov 14;369(20):1877-80

Expediting drug development--the FDA's new "breakthrough therapy" designation.

Sherman RE, Li J, Shapley S, Robb M, Woodcock J


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.

Category: Journal Article, Editorial
PubMed ID: #24224621 DOI: 10.1056/NEJMp1311439
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2013-11-16 Entry Last Modified: 2014-03-01