The US Food and Drug Administration (FDA) on Thursday released its proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program, outlining its performance goals and program enhancements for the program for FY 2028-2032.
The US Food and Drug Administration (FDA) on Monday released final guidance detailing the procedures for holding formal meetings between sponsors of over-the-counter (OTC) monograph drugs and the agency. This update revises the criteria for the types of meetings that sponsors can request and introduces hybrid meetings as an additional option for consultations with FDA.
