ARTICLE | Politics & Policy
FDA seeking Priority Review pathway for generics
September 26, 2016 7:00 AM UTC
FDA and industry agreed to propose an eight-month Priority Review pathway for generics that the agency considers to be "public health priorities." The news came in a notice announcing a public meeting on the reauthorization of the Generic Drug User Fee Act (GDUFA).
FDA said it will release a GDUFA agreement goals letter ahead of the planned Oct. 21 meeting. ...