Business · 11/08/2023Updated: 10/17/2026 · 1 min read
FDA Announces Draft Guidance for Industry on Biosimilar User Fee Act Meetings
Summary
The Food and Drug Administration (FDA) has released a draft guidance for industry outlining recommendations for formal meetings between the FDA and sponsors or applicants of biosimilar products, replacing a previous version issued in June 2018.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →