FDA Proposes Framework for Patient Enrichment Strategies

Powers, Marie
March 2013
BioWorld Today;3/27/2013, Vol. 24 Issue 58, p1
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 The author reports that the FDA issued a draft guidance on potential enrichment strategies for clinical trials and examined ideas such as adaptive designs and reduced data collection.


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