Impact of FDA's guidance on companion diagnostic approval
Scientia Advisors in the News
GEN quotes Harry Glorikian in article: "Concurrent Dx/Rx Review Will Require More Collaboration at FDA and More Outreach by Industry"
July 22, 2011In this article, Genetic Engineering & Biotechnology quotes Harry Glorikian of Scientia Advisors on the impact of the Agency's recent draft guidance on CDx approval. Glorikian provides caution "that if the FDA ultimately requires that a diagnostic be approved and in kit form before a drug is approved, that test has to be ready for use before Phase III trials, since the FDA must be able to look at data in which patients are stratified using the exact same technology in clinical trials that will be used once the drug is on the market."
"This implies that there will be an even greater hurdle to drugs being developed for launch with a companion diagnostic, and pharma companies will be even more reluctant to take this path," Glorikian told GEN. "Ultimately, it will result in a net increase in the time and cost of drug development."
The full article is available at Genetic Engineering & Biotechnology News.
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