Login

NON-SUBSCRIBER OPTIONS
FREE TRIAL   |   NEWSSTAND

FDA Will Start Holding Stakeholder GDUFA Meetings In October

By Beth Wang / September 14, 2020 at 7:19 PM
FDA plans to begin holding monthly generic drug user fee meetings with stakeholders in October, according to a Monday (Sept. 14) Federal Register notice. The agency calls for stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, to notify the agency by Oct. 8 of their intent to participate in regular consultation meetings on GDUFA reauthorization. FDA posted its Federal Register notice a week after sending a similar announcement through its CDER...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.