Industry Looks At 21st Century Cures To Set Stage For PDUFA VI

Representatives from the pharmaceutical and biotechnology industries said last Friday (Dec. 12) they expect work on the bipartisan 21st Century Cures initiative this spring to be a staging ground for negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA) in 2016 and 2017. Industry leaders also said they expected the biotechnology industry to enter the negotiations with FDA as an equal partner with the pharmaceutical industry, speaking on a PDUFA VI panel at an IIR-sponsored FDA/CMS...