S 3510
Biosimilar Inspection Modernization Act of 2025
Jurisdiction
US Congress
Session
119th Congress (2025-2026)
Last updated at
Jun 14, 2026, 8:48 AM
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Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
This bill, the Biosimilar Inspection Modernization Act of 2025, aims to improve how the Food and Drug Administration (FDA) inspects facilities that make biosimilar drugs. It directs the FDA to hold a public meeting to discuss using ‘mutual recognition agreements’ for inspections and to create a report with recommendations for expanding their use. The bill also requires the FDA to update its inspection processes and tools to be more flexible and risk-based, including utilizing remote assessments and addressing staffing challenges within the agency.
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