FDA Schedules June 15 Public Meeting To Kick Off GDUFA Negotiations

FDA will hold a public meeting June 15 to kick-off the Generic Drug User Fee Act (GDUFA) negotiations for the second iteration of the program. The current version of GDUFA expires in at the end of September 2017, leaving the agency and industry roughly two years to negotiate the next provisions. FDA is required to hold a public meeting accompanied by a 30-day comment period following the meeting, before officially starting negotiations with industry. The agency, in a Federal Register...