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- Title
Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation.
- Authors
Downing, Nicholas S.; Krumholz, Harlan M.; Ross, Joseph S.; Shah, Nilay D.
- Abstract
The article focuses on the efforts of the U.S. Food and Drug Administration (FDA) to facilitate the approval of new drugs. It notes the FDA's approval of 188 novel therapeutics from 2005 to 2012 under different classifications including first-in-class, advance-in-class, and addition-to-class. It cites that advance-in-class therapeutics were reviewed more quickly considering their degree of innovation and the differences in use of special regulatory pathways.
- Subjects
UNITED States; HEALTH promotion; DRUG approval; GENETIC regulation; DRUG therapy; NEUROPHYSIOLOGY
- Publication
Nature Reviews Drug Discovery, 2015, Vol 14, Issue 11, p740
- ISSN
1474-1776
- Publication type
journal article
- DOI
10.1038/nrd4734