FDA offers an olive branch on 'modernization'

WASHINGTON - Having nearly wrapped-up negotiations with industry for a new version of the Prescription Drug User Fee Act (PDUFA), FDA has reached out to the biotechnology and pharmaceutical industries with an offer to jointly craft new FDA reform legislation.

At a meeting at FDA headquarters with top agency officials on Friday, Biotechnology Industry Organization President Carl Feldbaum and Pharmaceutical Research and Manufacturers of America President Alan Holmer were invited to join the agency in jointly developing a legislative proposal...