FDA To Hold June 5 Public Meeting On GDUFA Regulatory Science Priorities

FDA will hold a public meeting June 5 to develop its regulatory science priorities for generic drugs for fiscal year 2016 and has asked stakeholders to weigh in on six potential research areas. The 2012 Generic Drug User Fees Act (GDUFA) requires the agency to develop yearly science priorities in the generic drug arena; 2013 was the first year FDA issued regulatory science priorities under GDUFA. This year FDA is asking stakeholders to comment at the hearing, to be held...