Modernizes FDA inspections of biosimilar biological product establishments.
The Biosimilar Inspection Modernization Act of 2025 aims to enhance the Food and Drug Administration's (FDA) inspection processes for biosimilar biological product establishments. The bill mandates the Secretary of Health and Human Services to conduct a public meeting on mutual recognition agreements for inspections and issue a report with recommendations. It also requires the development of a strategic plan to address challenges in inspecting domestic biosimilar biological product establishments, including staff recruitment, communication, and inspection tools.
Included in complete analysis
- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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