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Drug Development in Serious Diseases: The New “Breakthrough Therapy” Designation
Author(s) -
Woodcock J
Publication year - 2014
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2014.23
Subject(s) - clinical pharmacology , food and drug administration , drug development , medicine , intensive care medicine , drug , pharmacology , investigational drugs , pharmacotherapy , drug administration , clinical trial
The US Food and Drug Administration Safety and Innovation Act (FDASIA) was signed on 9 July 2012. This law created a new “breakthrough therapy” (BT) designation program for investigational drugs and biologics intended to treat a serious disease and having “preliminary clinical evidence [that] indicates that the drug may demonstrate substantial clinical improvement over existing therapies on one or more clinically significant endpoints.” 1 Many questions have been posed about the impact of this new program on drug development. Clinical Pharmacology & Therapeutics (2014); 95 5, 483–485. doi: 10.1038/clpt.2014.23