FDA would update how it inspects factories making biosimilar drugs
This bill would require the Food and Drug Administration (FDA) to update its inspection methods for companies that make biosimilar drugs. This means the FDA would use more remote checks and create a plan to improve inspections at U.S. factories. These updates would improve how the FDA checks on these medicines.
Today, the Food and Drug Administration (FDA) inspects companies making biosimilar drugs using current methods, which may include some remote assessments and international agreements. If this bill passes, the FDA would be required to update these methods to use more remote checks and other alternative tools. It would also need to hold a public meeting and issue a report on international inspection agreements, and create a strategic plan to improve domestic inspections, including better communication with drug companies.
S 3510 · 119th Congress · December 16, 2025 · AI Summary by gemini-2.5-flash · 9/10
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2 filings mentioned this bill
Amounts reflect total quarterly lobbying spend reported to the Senate, not bill-specific spending. Source: Senate LDA filings.