Business · 07/03/2000Updated: 10/17/2026 · 1 min read
FDA Releases Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Summary
The Food and Drug Administration (FDA) has made available a guidance document outlining procedures for formal meetings between the agency and sponsors or applicants for certain drug products, as part of the Prescription Drug User Fee Act (PDUFA) program.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →