TITLE

Compliance program supports IND and IDE research applications

PUB. DATE
July 2009
SOURCE
Clinical Trials Administrator;Jul2009, Vol. 7 Issue 7, p77
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article focuses on the establishment of the Office for Investigator-Sponsored Investigational New Drugs (IND) and Investigational Device Exemptions (IDE) Support at the University of Pittsburgh in Pennsylvania in August 2007. According to office director Dennis Swanson, all sponsor investigator IND and IDE applications are required to be submitted to the U.S. Food and Drug Administration (FDA). The issues which led to the establishment of the office are explained.
ACCESSION #
42637414

 

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