TITLE

FDA Proposes Framework for Patient Enrichment Strategies

AUTHOR(S)
Powers, Marie
PUB. DATE
March 2013
SOURCE
BioWorld Today;3/27/2013, Vol. 24 Issue 58, p1
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports that the U.S. Food and Drug Administration (FDA) is concerned about its ability to get enough information to make conclusions about safety and efficacy claims in examining new drug applications and biologics license applications. The author reports that the FDA issued a draft guidance on potential enrichment strategies for clinical trials and examined ideas such as adaptive designs and reduced data collection.
ACCESSION #
86442010

 

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