Business · 03/10/2017Updated: 10/17/2026 · 1 min read
FDA Announces Draft Guidance for Industry on Formal Meetings with ANDA Applicants of Complex Products
Summary
The FDA is releasing a draft guidance to help applicants prepare for and submit meetings with the agency to discuss complex products under the Generic Drug User Fee Act (GDUFA).
Original source language: Federal Register — Food and Drug AdministrationOpen original release →