Personalized Medicine Does Not Fit In FDA's Current Scheme, Experts Say
This article was originally published in The Pink Sheet Daily
Executive Summary
"FDA has signaled several times that they are considering regulation of the space," says Personalized Medicine Coalition CEO Rosenkrans. But, "they aren't quite sure how to do it."
You may also be interested in...
Companion Diagnostics Spark Pharma Deals, But Still Mostly For Cancer
An inaugural review of the diagnostics sector newly published by PricewaterhouseCoopers contends that growing interest in personalized medicine is a key factor driving partnering deals between pharmaceutical companies and diagnostics developers
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.