FDA, industry leaders to discuss PDUFA reauthorization

Amid a great deal of disruption and uncertainty at FDA, one process, PDUFA reauthorization, seems to be moving forward in an orderly way.

FDA officials and industry leaders will meet Monday for preliminary discussions on PDUFA VIII. The session, formally designated as the wrap-up continuous engagement session for PDUFA VII, is expected to focus on the next round of negotiations, according to industry sources who spoke with BioCentury...