TITLE

FDA ruling may increase clinical trials

PUB. DATE
October 2009
SOURCE
Clinical Trials Administrator;Oct2009, Vol. 7 Issue 10, p109
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
This article reports on the possibility that the U.S. Food and Drug Administration's (FDA) new rule on expanded access to investigational drugs will lead to an increase in clinical trials via its advocacy of intermediate-size patient populations. The final rule of the FDA will be effective starting from October 19, 2009. LaDale K. George of Neal Gerber & Eisenberg says he is optimistic that the new regulations will enable sponsors to amend or create new investigational new drugs (INDs). There are public concerns over the proposed rule.
ACCESSION #
44312371

 

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