FDA Extends Sign-Up Deadline For GDUFA Stakeholder Meetings

FDA, as it readies to start Generic Drug User Fee Act (GDUFA) negotiations in earnest, has extended the deadline to April 30 for public stakeholders to register to take part in monthly meetings. The original deadline set by the agency was Aug. 14. The meetings with public stakeholders -- which include patient and consumer advocacy groups, health care professionals and scientific and academic experts -- run parallel to the closed-door negotiations FDA holds with industry to formulate a reauthorization package...