Vasogen Trial Stymied by FDA ReversalVasogen Trial Stymied by FDA Reversal

FDA has reversed itself over patient-recruitment and statistical-analysis issues for Vasogen Inc.'s Celacade System, a combination product that treats heart inflammation. Responsibility for lead review has been switched from CDRH to CBER (though the product will remain regulated as a medical device). CDRH had asked the company to use a Bayesian study design, but it now says the approach is not justified because of concerns about how patients in the product's two main studies were recruited.