Expanding Patient Access to Investigational Drugs

Summary: With drug approval times taking an average of 8 years from entry into clinical trials to full U.S. Food and Drug Administration (FDA) approval, patients with life-threatening and severely debilitating disease and no reasonable therapeutic options are advocating for expanded access (EA) to i...

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Bibliographic Details
Main Author: Gail A. Van Norman, MD
Format: Article
Language:English
Published: Elsevier 2018-04-01
Series:JACC: Basic to Translational Science
Online Access:http://www.sciencedirect.com/science/article/pii/S2452302X17302917