www.fdanews.com/articles/138263-expert-comparative-effectiveness-mandate-would-burden-industry
Expert: Comparative Effectiveness Mandate Would Burden Industry
July 8, 2011
Mandating comparative effectiveness research (CER) for drug approvals as part of Prescription Drug User Fee Act (PDUFA) reauthorization is unnecessary, would yield ineffective data and would add a major hurdle to the development of new drugs, an industry expert says.
Washington Drug Letter
Washington Drug Letter