Business · 21/07/2025Updated: 10/17/2026 · 1 min read
FDA Announces Final Guidance for Industry on Biosimilar User Fee Act Meetings
Summary
The Food and Drug Administration (FDA) has released a final guidance for industry on formal meetings between the FDA and sponsors or applicants of biosimilar products, finalizing a draft guidance issued on August 11, 2023.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →