CDER Director George Tidmarsh’s biomarker comments, in his own words 

Comments George Tidmarsh, director of FDA’s Center for Drug Evaluation and Research, made about accelerated approval at a patient advocacy meeting Tuesday attracted a great deal of interest among patient advocates, biopharma companies and FDA staff. As BioCentury reported, Tidmarsh said FDA will look back at past accelerated approvals to compare surrogate endpoints with clinical outcomes, including, but not limited to, oncology drugs.

Tidmarsh also called on industry to avoid crossover designs in confirmatory trials, noting that they can obscure overall survival outcomes. ...