EUA or eIND? Testing drugs in an emergency

June 2010
IRB Advisor;Jun2010, Vol. 10 Issue 6, p67
The article focuses on Emergency Use Authorization (EUA) process and emergency Investigational New Drug (eIND) regulation, drug distribution mechanisms used by the Food and Drugs Administration (FDA). It discusses two mechanisms based on the H1N1 emergency that happened last 2009, where the FDA was reportedly issuing EUAs for antiviral drugs. Andrea Meyerhoff, an infectious disease specialist at Johns Hopkins School of Medicine in Baltimore, Maryland, suggests that eIND should be used instead of EUA.


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