Business · 05/06/2018Updated: 10/17/2026 · 1 min read
FDA Announces Draft Guidance for Industry on Biosimilar User Fee Act Meetings
Summary
The FDA is releasing a draft guidance outlining recommendations for formal meetings between the agency and biosimilar product sponsors or applicants, replacing a previous guidance issued in 2015.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →