An Analysis of US Food and Drug Administration Clinical Hold Orders for Drugs and Biologics: A Prospective Study Between 2008 and 2014
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Link
http://link.springer.com/content/pdf/10.1007/s40290-015-0105-7.pdf
Reference22 articles.
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3. Food and Drug Administration. Investigational new drug applications; clinical holds-FDA. Direct final rule. Fed Regist. 1998;63:68676–8.
4. Wilson LG. The crime of saving lives. The FDA, John Najarian, and Minnesota ALG. Arch Surg. 1995;130:1035–9.
5. Ciment J. Gene therapy experiments put on “clinical hold”. BMJ. 2000;320:336.
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