FDA, Industry, Lawmakers Praise PDUFA Resources For Breakthrough

House lawmakers, FDA officials and industry stakeholders all praised the success of the agency’s breakthrough designation in lowering drug development times, and stressed that the pending Prescription Drug User Fee Agreement (PDUFA) will bring important resources to the breakthrough effort. The widespread commitment to the designation at a House hearing Wednesday (March 22) is likely to please FDA Commissioner-nominee Scott Gottlieb, who has proposed sweeping reforms to build upon the breakthrough program, which he has said speeds drug entry to...