When does 'compassionate use' help with options?

October 2008
Clinical Trials Administrator;Oct2008, Vol. 6 Issue 10, p111
This article focuses on investigational new drugs (INDs), also called compassionate use drugs, which are in later phase trials where the U.S. Food and Drug Administration (FDA) has allowed the sponsor to apply for an individual treatment IND. Particular focus is given to the origin of individual treatment INDs. Mark S. Schreiner of the University of Pennsylvania explains the idea of a treatment IND. LaDale K. George of Foley & Lardner says the individual treatment IND process is misguided.


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